Angio-Seal, StarClose and Vascular Access and Closure Devices

Current Postings (154)

• My 81 y/o healthy Mom had an angiogram 7/12/10, and had immediate cold and painful leg. Was first told it would get "better" and would "dissolve" (yeah, walk it off~). Weeks later she showed me a card she was "given" talking about "her" angio-seal. The only "care" she was given from numerous complaints was strong pain pills, weeks 2 thru 4~! Finally a "specialist" she initiated contact with ultrasounded my Mom's leg on August 13th, and he was shocked to find it so blocked, and that Mom had had to put up with such pain and poor responses to her month of prior initiations and complaints to her original Angiogram Doctor. He scheduled immediate surgery for "removal" 8/16, with success.. but what a mess in Time PAIN Frustration LIFE. The leg is Still in pain but we hope a good-pain as it is "red" and we hope "healing & recovering" from a month of nearly no blood! Thanks Angio-Seal or its Inserter person~~~. For me now (and any I tell), I will request to lay around for a few hours and skip the gadgets!!!! For those with issues, my heart goes out~ get a clear 30 minute ultrasound and a Dr who is willing to address someone else's mess up. (saying it is in your head is just CRUEL~!.. horrible)
Kevin in OC California, Huntington Beach, California, August 18, 2010

• If you go into the cath lab again for another procedure, ask them to seal you with a "MYNX" closure device. This device is superior! There is no pain associated with the deployment. It is not made of animal product, like angioseal. It will dissolve in 30 days leaving nothing behind in your groin area to aggravate the site. You won't have additional scar tissue and you won't have pain for years to come! I had this device here in Philadelphia, PA. 1 yr ago. I had no issues, no pain, no complaints! I am allergic to certain foods and metals. If I had a an Angioseal I would have had an allergic reaction, if I had starclose I would have as well. Report all your complications to the FDA!
Clark , Philadelphia, Pennsylvania, USA, August 18, 2010

• Depressed in Orange County -- You'll find a number of other similar posts in the related topic, "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty". Without further investigation, it's not possible to say if the Starclose device is in fact the problem. You may be suffering a complication resulting from trauma to the femoral nerve, which can occur during the procedure, and may have nothing to do with whether or not a vascular closure device, such as the Starclose, is used. Collected data shows that femoral nerve trauma/damage is an infrequent complication of femoral catheter-based procedures -- however, our Forum has many posts about this issue. Have you reported your problems to the interventional cardiologist who did your procedure? Perhaps a referral to a neurologist might help. Diagnosing the cause of your pain and numbness might point a way to treatment.
Forum Editor, Angioplasty.Org, August 9, 2010

• Starclose 4-24-10 pain every since numbness tingling all over right leg, tired feeling, heaviness, lower back pain i was in a wheel chair for 2-weeks or more problem walking sitting for long periods of time. Dragging my foot by the end of the day. have had no problems until that device was put in me. that device may help with recovery but the lifetime you have left is in pain. that device needs to be off the market until long term studies are done.
depressed and unhappy, Orange County, California, USA, August 9, 2010

• I had a heart cath done on 7-21-10 and basically have had no complications. I do have a small lump under the Angio seal site and it is tender but I'm chalking it up to being so new. I have to go see my doctor in the next week or two and will ask him about it if it is still tender.My doctor had me come in a week before the surgery and the nurse went over everything that they were going to do to me in detail and answered all of my questions thoroughly.It is a shame that not all doctors do this. I was upset that I had to take time off and go in for it but now am glad I did.My heart center is fantastic and so was the hospital. I can only say that if they are going to do a procedure on you and you know in advance...ASK QUESTIONS! They WORK FOR YOU! I feel much better since I had my heart cath and am glad I had it done.It's a shame that not everyone has a happy outcome. I wanted to give some of you a positive side to the procedure and Angio seal. So far so good.
Happy in Jax, Jacksonville, Florida, USA, August 4, 2010

• I had an angioseal inserted in 2008. Since I have had enormous amount of pain and swelling in my right thigh agets bind groin area. My thigh is swelling more and more each day and the dr is telling me it is unlikely to be happening from the procedure. It was recommended that I see a psychiatrist. I didn't because the pain along with the swelling is not my imagination. I am angry because I have been living with this pain for a few years now and I am afraid that the longer someone waits to correctly diagnose what is wrong the shorter my life span will be. I am at my wits end and don't know what to do. The pain is constant, the swelling ongoing and my ability to walk has been affected greatly. I NEED HELP ------- IMMEDIATELY!
Groin Pan in Delaware, Newark, Delaware, USA, July 26, 2010

• Michelle-Indiana and Concerned Patient from Pennsylvania -- you've both posted to the topic on "Vascular Closure Devices". It's not clear from your posts that your problems are from a closure device or even which device you got. Check out the topic, "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty" and maybe post to that one. Also can you give the Forum a little more detail? And to Sara in Finland -- have you reported your symptoms to the cardiologist who did the angiogram?? You should, so he/she knows about it for other patients -- also you might get some specific assistance from someone who IS familiar with the StarClose clip. Thanks to all for posting!
Forum Editor, Angioplasty.Org, July 21, 2010

• i had a heart cath 4/16/2010 and i still am having problems swelling blood clot it is sad that i got pressured into this procedure by a doctor and now i am suffering its been 4 months
michelle-indiana, Genteryville, Indiana, USA, July 21, 2010

• I'm a 39-year-old woman who had catheter angiography to rule out an AVM on April 28. The femoral puncture was closed with a StarClose device. Everything was fine (no AVM, the puncture healed cleanly) but the soreness and pain that was supposed to pass in a week still hasn't gone away. I can feel the device (but there's no significant bump or swelling, nor has there been). An ultrasound scan was done two weeks ago, but everything "seemed normal" (but the MD who did the scan it had never heard of StarClose devices before). Sitting or doing (or wearing) anything that puts pressure on my groin makes things worse, so I take painkillers daily. Any advice or tips on how to make things better and hopefully be able to live without medication again?
Sara, Southern Finland, Europe, July 13, 2010

• Had a heart cath done about 2 yrs. ago. Couldn't walk more than 3 steps without falling for 3 days. Could not turn my right foot at all without severe pain. Immediately started gaining weight also 1st week I had the cath done. Still have pain in right groin area travels into the lower part of my back, still fall at times now, legs & feet are always swollen, pain in stomach. If pain is severe enough at times I can not lift my legs to walk have to slowly slide my feet along to get around. Nothing was explained or was I told anything would be inserted into the groin area. I also have numerous allergies to meds, latex, metals, & other things. What would cause all the swelling, weight gain, pain, & lack of mobility?
Concerned patient, Duncansville, Pennsylvania, USA, July 11, 2010

• @ frustrated in Michigan post 6/19. Among other things...Ditto, strange things, almost exactly as you describe. Cardiac cath on 5/10, 3 stents in on 5/11. Very upset about the whole thing, and do not trust anything that was done. (I have a lump 2 inches below site, was told cyst, unrelated, don't worry. we'll see) Thanks for any updates or info you find out. I'll do the same.
uneasy, Highlands, New Jersey, USA, July 7, 2010

• Anniegurl -- have you discussed the possibility of doing the procedure through the wrist artery (a.k.a. transradial) with your cardiologist? You can find out more in our Transradial Access Center.
Forum Editor, Angioplasty.Org, June 29, 2010

• I had 2 stents inserted 7 weeks ago with manual compression...2 hours before sheath removal then 6 hours bed rest. I am having another stent inserted in 2 days and I am considering angio seal. The idea of 8 hours on my back, using a bed pan makes me want to go the angio seal route...any opinions?
Anniegurl, Sunrise, Florida, USA, June 29, 2010

• Getting heartwise -- the angio-plug is most likely what the techs call the Angio-seal -- there are other "plug" type closure devices, but Angio-seal is the most widely used. The most important thing is not to exert yourself too much for a short while, until the angioseal has set. The seal is made of collagen, which biodegrades after a few months. Not sure which model was used, but here's some info on the device, which is made by St. Jude Medical.
Forum Editor, Angioplasty.Org, June 28, 2010

• Hi. Is an angio-plug the same as an angio-seal? I had an angio plug put in yesterday after a cardiac cath and a stent installation. All went well. Just wondering what the plug actually looks like. I know it seals the area at the artery where they placed the sheath to do the cath. Just don't know what is under this gauze pad and tape. Thanks.
Getting heartwise, Hamilton, New Jersey, USA, June 25, 2010

• LKcurious -- a small percentage of people may have a hypersensitive reaction to bovine collagen, which is what is used in vascular closure devices.
Forum Editor, Angioplasty.Org, June 25, 2010

• Help w/ Info Please! I had angio w/ collagen plug a week and a half ago. I don't have any heart, artery or health probs. I am a 40yr old, 140 pd woman. I have had 9 neck and back surg's and I have a pedicle screw pressing against and displacing my vert. artery. I was in the hospital for two hours after the procedure, then sent home. My right thigh, groin, and down my right leg were very painful and puncture site was swollen. No fever etc.... Then, three days ago, pain stopped, swelling reduced. It seemed good then after about 20 min. of walking around in the house and cooking dinner the puncture site swelled up like a golf ball and twitching of my thigh muscle was obvious. This has continued and doc says not to worry since I'm not showing signs of infection or bleeding. OK! But, why is it bruised, hard, swollen like a golf ball, and all of the above increases w/ activity? What could this be???? Any ideas or similar complaints. Thanks.
LKcurious, San Diego, California, USA, June 22, 2010

• I had a heart cath two weeks ago. The StarClose site is driving me crazy with I best can describe as "irritation" and itching. I can feel the little bump. Nobody told me that it contained nickel and I do have an allergy to nickel, i.e., cannot wear earrings with nickel in them. Now what do I do?
Gail, Washington State, USA, June 20, 2010

• I had a heart cath done on May 14,2010. I developed a 3 inch lump above the entry site.They did a doppler said no clot. I started getting pain in my right leg and behind my knee and tingling in my foot. At times my calf gets real tight feeling. I have been back to the Dr. every week since. The pain behind my knee is so bad I cannot stand for long periods of time. The tingling in my foot is still there on and off. I also get a cool feeling almost like something is running down my leg. My cardiologist and my family doctor is saying this is not from my heart cath. I am frustrated. I need answers.
frustrated, Michigan, USA, June 19, 2010

• Dear "Underreported Adverse Events" -- We beg to disagree regarding your statement about the negligence of the hospital staff in your reply to Jim M. Retroperitoneal hemorrhages can be tricky to diagnose -- and they are often unrelated to the vascular closure device. But certainly patients should be sent home with instructions about what to watch for regarding bleeding complications. The staff may have had no signal that there was a problem. However, since this patient was done as an outpatient cath, it might give pause to the growing trend of releasing patients the same day. We should also point out that this type of bleeding complication does not happen when the transradial (wrist) approach is used.

We agree, however, with "SayNoToClosureDevice Okay" that many of these adverse events are not reported by the doctor or hospital (in fact, they often are not aware of these events, since patients tend to go to their primary care physicians with their complaints -- or write into this Forum -- and the adverse event info never gets to the interventional cardiologist who did the procedure in the first place).
Forum Editor, Angioplasty.Org, June 18, 2010

• Review the July 5, 2009 post. I encourage everyone to report their issues to the FDA, and do not assume or believe that their doctor or hospital has reported this to the FDA.
SayNoToClosureDevice Okay, Winston Salem, North Carolina, USA, June 16, 2010

• Jim M of 2009. Absolutely negligence on the part of the hospital staff. Other patients retro hemorrhages are detected and corrected. Death was avoidable. Watch the FDA website for announcement concerning Angio-Seal investigation which may appear in 2010 or early 2011.
Underreported Adverse Events, Winston Salem, North Carolina, USA, June 16, 2010

• As far as I can determine there is no attorney in Winston Salem named Marc Hepp.
Doubt it, Winston Salem, North Carolina, USA, June 16, 2010

• On April 21, 2010, I had a heart cath and after the procedure was finished my daughter handed me a card which the nurse had given to her to put into my wallet. I was never told of this device prior or asked for my permission. I have many allergies to many meds, foods, etc and I do wonder if any of this was even looked at prior to putting this angio seal in me. I do have a burning sensation sometimes, nothing I can do about it, but I do feel the doctor should have discussed this with me prior to the procedure.
Marie R., Michigan, USA, June 15, 2010

• My Angio-Seal was installed 3/31/10 and now two and a half months later I have begun having persistent groin pain at the site of the seal. My Cardiologist's PA says this is just scar tissue from the incision and will eventually go away. Should I be concerned?
WTC, Conroe, Texas, USA, June 14, 2010

• I had a heart cath done on May, 23, 10. I was not told until I was sent home that they used a angioseal. A few days later I started having calf, toe and hip pain. I finally got a vascular dr to look at it and he said they implanted the angioseal too deep into my femoral artery causing blood flow to be slow. He performed a angioplasty and pretty much said it was in my head and not to come back. to this day I am still having leg and toe pain and have severe itching and rash on my right groin. I have never experienced anything like this. Any advice? I'm ready to seek legal consultation
40 year old in pain, Rogersville, Tennessee, USA, June 13, 2010

• I had a heart cath 23 months ago. I was 35 at the time. The doc placed an angio seal in my right femoral artery for closure. I woke up complaining of my right foot numb and tingly I told the nurse and doc if i walked on my foot i would break it. an hour later i was being sent home with now a numb leg from the knee down, telling me it would go away. 6 hours later my leg was without blood flow, was white and the skin was drawn up. I went to the ER where they had to remove part of the artery. It took 5 months to heal the wound. I still suffer with major pain. With no help from Drs in pain relief. I just had another cath in the left to fix the right artery repair where the plastic collapsed from the first repair. I now have two swollen lymph nodes and pain on the left. They did not use an angio seal, but my leg does not hurt. I have had 3 atty's turn me down, because this was just a risk to the procedure. i will have to have surgeries for the rest of my life and my even lose my leg in my 50's because of the angio seal. my life has come to a stand still, i go to work and come home and sit because of the pain. I am grateful , but it is ironic, nothing was wrong with my heart.
HEA OKC, Oklahoma City, USA, June 11, 2010

• I had a cath today, and they used the angio-seal, I have no problems, and find that it'a a great device. It let me get back on my feet quicker. As others have posted, complications are rare, but that's all people talk about, so they don't hear the positives.
blueyedmedic, Edison, New Jersey, USA, June 7, 2010

• I found this site while researching the angio-seal for work as a nurse chart auditor. I'm disheartened to see so many people practicing medicine without a license & willing to believe the conspiracy theory related to health care. My 74 year old father refuses to see a doctor because "they're all crooked,in bed with insurance companies, after my money." Well, he smoked 3 packs of Camels a day for 50 years many of which were spent working in an enclosed office with others smoking. He had 30 years of very heavy alcohol use & has had meat & potatoes for every meal of his life - adding 3-5 eggs to breakfast. But he couldn't possibly have ANY cardiac or lung issues. Never mind that he gets short of breath from the bedroom to living room of a 1400 sq ft home, is gray & cannot bend over without blacking out. There's nothing wrong with him; in fact, he hasn't seen a doctor in 10 years! And look at the money he's kept out of "their" hands. He'll be dead soon. I've accepted that.What I can't accept is that people would rather find someone to blame than be part of the solution, feel better and LIVE! We're not all out to get you. Report your problems via the methods listed here. Get a referral. Heal. Move on.
Rhonda, R.N., Missouri, USA, June 7, 2010

• Dear Legal Nurse- We are not just "complaining" Most of us were NEVER asked if we wanted these devices implanted. I did not know that I had the first one until it was already INSIDE me and the Dr gave me the card and it was THEN I was able to ask about complications etc. I was also never asked the second time was one implanted either. That is the problem! I'm glad I had my annie coiled, but wish I was allowed to make a decision on having the starclose placed inside my body as I was allowed to decide on my coiling. My cardiologists agrees with me too!
CM, New Hampshire, USA, June 4, 2010

• It has been over ten years since a perclose suture device was deployed incorrectly and I still suffer every day with ileohypogastric and inguinal nerve pain. I had it removed three years later, only to learn the damage was done...and no doctor knows how to help me. I have seen neurologists,etc... pain doctors,who put me on every narcotic...that still didn't help. I refuse all narcotics now. I was started on Lyrica which finally did help some...but I still am in so much pain! I need to find a physician to ablate these nerves, if it is possible. No neurologist in Pittsburgh has been found ,so I have calls into Cleveland Clinic now. If anyone can help me find a specialist for this I would greatly appreciate it. I try to be very active as I was before this nightmare began..and can't!!! And they still keep shoving these into patients to save time and money.... but look how many have been hurt or even killed!!!!!
Donna R.N., C.D. Ladani cardiology associates, Grove City, Pennsylvania, USA , May 31, 2010

• I had a vascular closure system placed by my cardiologist last September after a heart cath was performed. Two months ago I started experiencing severe pain on my right hip traveling all the way down to my leg. I am also experiencing charley horse pains like never before. The groin area where the Perclose was placed is tender to the touch and even lying down I feel like someone is pricking me with a needle or knife. Do not allow yourself to have this device placed in you.
Blanche, McAllen, Texas, USA, May 30, 2010

• In response to Legal Nurse, yes, there are risks to everything. But the medical community owes it to each patient to see that INFORMED consent is given for procedures. Many patients are not educated on options or complications prior to invasive procedures. I myself have a Starclose which is made of titanium nickel alloy, but no one asked if I had a metal allergy prior to its insertion, however, each new staff member asked for my birthday when they entered my room. It seems THEY didn't want to assume any risk, which every non-rocket scientist knows is part of life. The 2 staff members that I did inform of my allergy to base metals didn't seem to think it important enough to mention in my paperwork. People should not have invasive procedures without the education and information they need to make decisions that could affect their quality of health and life post-procedure. That is the role of the staff of doctor's offices and hospitals to provide not only the means to remedy but the information to make the decisions necessary to remedy in full disclosure prior to surgery, not in a pamphlet handed to you post-procedure.The kicker for me? My stress test was false +.
Just Another Guinea Pig, Carmichaels, Pennsylvania, USA, May 28, 2010

• Procedure 5/4/2010... right leg, Female, 51 yoa. My RIGHT upper thigh and knee, and foot has a feeling of numbness, The feeling is not unlike that of when the foot has is "aleep" , but no tingling, just numbness, and the foot has intermittent pain. just want to feel normal, it's been two weeks, but will this ever go away????? How soon can I resume walking/ running/ wear 4" heels????? I'm almost sorry I had the procedure!!!
Dee, El Paso, Texas, USA, May 18, 2010

• OK everyone.... there are ALWAYS risks to ANY invasive procedure no matter what it is. It does not take a rocket scientist to figure that out. Additionally, you can ASK questions before any procedure is done and ask what the risk & complications are. Stop the deflamation. The procedure that you are referring to most likely gave you or your loved one more years added to your lives. Get a second opinion if needed, then drop it. Enjoy the EXTRA time you have to LIVE.
Legal Nurse Consultant, Wichita, Kansas, USA, May 17, 2010

• My body rejected the Mynx Vascular closure device. I had a heart cath two weeks ago and began to develop a lump at the site of insertion almost immediately. Three days after the cath I was in another state for a family emergency. The lump became unbearably sore,swollen, red and within five days looked like a boil. The first Urgent care dr wouldn't touch it but after conferring with the cardiologist gave me massive doses of antibiotics in shot and pill form. The next day the site was worse. A different dr at the same urgent care lanced the site, sent a sample to the lab, and removed the Mynx. Days later the report came back that my body had rejected the device. What would have happened if it were left in????? My 14 day antibiotic routine of six pills a day is kicking my butt and making me ill with diarrhea. When will this stop?????
PG, Cleveland, Ohio, USA, May 16, 2010

• Wanda H. -- Don't panic. Angio-Seal is the most widely used femoral vascular closure device. What you read on our Forums are all the complications. Unfortunately the vast majority of patients who have had caths or angioplasties and who have had no complications from Angio-Seal (and that would be 94-97% of patients) seldom post here. So you're reading a distillation of the worst stories -- helpful to patients who have had problems and are looking for support -- but only anxiety-producing for people who are concerned but who have not had anything go wrong. One of the issues we feel is that most patient consent forms are blanket in nature -- and each device used is not subject to a separate consent. (That's our understanding. If any healthcare professional out there knows differently, please post.) In any case, many patients have posted that such a device was used without their consent -- that's not technically correct, but the impression only breeds mistrust.
Forum Editor, Angioplasty.Org, May 3, 2010

• HELP my husband had the ANGIO-SEAL put in this morning{04-03-2010} with out us knowing!!!!! I hope he is going to be ok??? someone please put something good.
Wanda H., Georgia, USA, May 3, 2010

• To Nancy Holland and Rocky A....you can see my posts regarding the Mynx Vascular Closure Device below (10/16/2009 and 12/7/2009). Even today, 6 months later, I'm not fully recovered. The scrotal hematoma generally healed, but not fully, as there is still discoloration and some discomfort from absorption or blood clots eventually dispersing into other areas of my genitals. During my last visit to both my urologist and cardiologist about 6 weeks ago, they both said that this is a normal result, and it will get better, but honestly 6 weeks later, it looks the same. The cardiologist mentioned again that this was the first and last time he (and I believe his team) will ever use the Mynx Vascular Closure Device...he has not used it since.
Lew, New Jersey, USA, April 30, 2010

• I too had a Star Close device after a angio-catherization back Sept. 09. I forgot about it until I changed wallets and found the Star Closure card in my wallet. This was also inserted without my permission. The card was given while still groggy and I never gave it another thought until now. I have been having intermittent pain in the same area as the Closure. I have been thinking its my appendix. I also just finished a cross Country trip and had total hip pain several days on our vacation. Should I let my Cardiologist know about this now or wait for my appointment with him in August 2010?
Peggy Su, retired, Port Orange, Florida, USA, April 26, 2010

• I recently had a Star Close clip placed. The brochure I was given to me to carry around states "The Star Close Clip" is MRI compatible. I too was not asked my consent about receiving this device and I am concerned about any future issues that it may cause. I would have preferred to have been given a choice.
Deborah C, Springfield, Tennessee, USA, April 24, 2010

• I had a mynx vascular closure device on the 6th of april and today is the 21. I am in agonizing pain and I am trying to find an answer before I go to the hospital
Nancy Holland, Magnolia, Mississippi, USA, April 22, 2010

• I am a 43 year old active female who underwent a Heart Cath 3/6/2010. I was not informed that the Angio seal was being used either. Cath was clear, no blockages, but 10 hours after the cath , I started having numbness and tingling in R leg and the leg started turning purple (still impatient) I called for the nurses and was told they called the Dr. and i would have an ultrasound the next morning. The next morning had the ultrasound and was Dx. of having a blood clot at the site of insertion. I was convinced this was caused from the cath. I still have pain at the site and a lump remains there. I was put on blood thinners and have to give myself injections of lovenox twice a day. This will go on for 3 months i was told. I also had an appt. with the Hematologist 1 month later and he informed me that he had a cath a week later and developed a hematoma at the site. He and the Cardiologist are friends so i was amazed he told me this info... but he said the Cardiologist was going to report this to the manufacture of the angio seal. In the mean time i will report this to my Lawyer... Thanks for the site...
Kathy Begue, Fort Campbell, Kentucky, USA, April 20, 2010

• We're not sure how we feel about posts like the one below from a lawyer obviously trying to get clients for a law suit. We would like to hear opinions from readers if this type of posting is of any value. As for under-reporting adverse events, patients can report an adverse event from any device directly to the FDA -- http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm. But we agree that all adverse events of vascular closure devices and access site complications in general are under-reported (most cardiologists we've discussed this with agree). In fact, the American College of Cardiology did a study from the NCDR database a few years back and showed that VasoSeal, the first vascular closure device marketed in the U.S., had far more complications than its competitors -- and this resulted in VasoSeal being taken off the market. The reason vascular closure devices were invented is to help patients ambulate (walk) sooner, as well as make the procedure quicker. But they add costs to the procedure (a few hundred dollars) rather than lower them.
Forum Editor, Angioplasty.Org, April 20, 2010

• I'm an atty- I believe post-Perclose complications are being under-reported and mis-reported to the FDA and uninvestigated by Abbott Vascular. These devices had one purpose only- quicker hemostasis means less costs and more patients per hour. Almost all of the studies done have been conducted by research organizations who are dependent on Abbott, and don't have any relevancy to what's happening in every-day cath-labs. I've caught a whole batch of people dirty as hell on a procedure, and when I studied the MAUDE reports it's clear they're for compliance- not safety. Does this sound familiar- "Although requested, no additional information was available."? It should. It's contained in 95% of Abbott's required reports over the last four years. Write me if you're out there- mhepp@bellsouth.net. Marc
marc, Winston Salem, North Carolina, USA, April 20, 2010

• i for one had the angioplug inserted after 2 stents in 07-08,i couldnt walk more than 100 steps without stopping to rest, blood flow was restricted, i searched for 6 months to find a vascular surgeon to undo this mess, found a doc at columbia hospital in nyc,, wow i am fine now thanks to Nicholas Morrissey, M.D. I owe u sir.
Mike Eisner, New York, USA, April 3, 2010

• I am a 53 male, i had a cath done on march 4, 2010. they used the mynx closure. the next day i developed a lump right above the entry site near the groin. i had 2 dopplers and they said everything is fine. i had to stay in the hospital for 2 days because the vascular surgeon made an incision on the lump. it drained so slightly. they didn't say it was a hematoma either. over 3 weeks later and I'm still on antibiotics, now they are telling me that its probably from the mynx. did anyone else have this kind a reaction to the mynx. i might have to have more surgery. or is this dr error!!!!
Rocky A, Bayville, New York, USA, March 27, 2010

• I had a heart cath done on January 26, 2010. I went for a routine heart assessment test done by the hospital. I ended up in the heart cath lab where I was given a heart cath. I was told everything was fine. I was not awake during the procedure. When I left for home they handed me a pamphlet telling me about the Angio-Seal they had used. After a week of being home with not being able to walk because of the pain I called the cardiologist about how bad my hip and thigh and leg hurt. She had me come in. She sent me to the emergency room for an ultra sound to see if I had a blood clot. There was no clot. They did say I had swollen lymph nodes. I went back a week later to the cardiologist and they told me they thought it was the sciatic nerve. It hurts really bad when I get up from a sitting position. Its hurts clear down my leg into my foot. Don't know if its the Seal or what. I need to get some answers. Its been almost a month. Wished I had been informed about the Angio-Seal before instead of after.
Sandy H, Kalamazoo, Michigan, USA, March 25, 2010

• I had a cardiac ablation to my heart on 7/10/2010, and the site of where they went in and placed the two Angio-Seals was tender for three months, it is now 3/19/10 and in the last week, I have an incredible amount of pain radiating from the site. I kept wondering, what could this be from until it dawned on me that this is from the entry site from the ablation and where the Angio-Seals where placed. Came into work this morning to do research and much to my surprise, others are having the same problem, pain radiating and shooting down my leg and to my upper hip. Please, anyone who is finds they are having this too after months of having the surgery, email me @ shopgirlofny@msn.com (Monique). This is really painful, feels like a nerve is causing the issue from the vascular seal. I was "NOT" told they were using this, or given any options at all. I didn't even know how they closed the entry site, until I found weeks later in my bag that I brought in to the hospital the Angio-Seal card and brochure that I had to carry with me for ninety days. The nurse slipped it into the zipper section on the inside of my bag. Thank God I eventually checked the bag or I would have never known. Crazy!!
Monique Joyner, New Orleans, Louisiana, USA, March 19, 2010

• re: Tammy - "if there are no negative consequences to the doctors or hospitals, where is their incentive to get it right the first time?" what kind of nasty comment is that? it's unfortunate your husband suffered a complication from a procedure that was done to save his life, but doctors are not routinely in the habit of doing things carelessly so that people come back to the hospital with complications. that is the very last thing we want. do you think we enjoy taking care of disgruntled patients who want us to suffer negative consequences? i mean, really - that's incentive enough!
WI, Minneapolis, Minnesota, USA, March 13, 2010

• Concerned Wife -- you posted under the "Vascular Closure Device" topic -- did your husband have one of these? Because there is also a topic on "Complications from Femoral Site Catheterization" -- and it may be more appropriate, although they are related. A number of patients report that this immediate pain and problems in the leg do go away in a few days or so -- of course, some complications last longer. Have you discussed this with the cardiologist who did the angiogram. If for no other reason, he/she should be aware of the complication. Another reason we have been writing about CT Angiograms as a possible alternative to nuclear stress tests or to invasive angiography in patients at intermediate risk or who have no symptoms but do have a positive nuclear stress test
Forum Editor, Angioplasty.Org, March 14, 2010

• My husband had this procedure done just a few days ago. He also was not informed until he was being discharged. I've searched since on recovery time. He has trouble walking and pain. He had a nuclear stress test done and was told there might be some blockage. This test came back clear. We tried to tell the dr. no but he pressured him into it. Now my husband will more than likely not be able to return to work. I feel that some drs. need to be held accountable for not informing patients of the serious of this. It took away my husband's livelihood. And if it doesn't absorb then what will it do? Our personal phys. wants the same answers. No one informed us nor did they give any options-such as the arm. Right now I feel he's looking at a long road to recovery. The dr. that did the procedure didn't even come back in to check on him. I don't know much about today's drs. but it makes me wonder if this is why health care is such an important issue today. And how many people have to be put through this kind of mishaps before they get it right.
concerned wife, none, Fort Worth, Texas, USA, March 13, 2010

• Hi, I was in the cath lab on Aug 21, 2009 and i had a mynx put in. they got me up to walk before i went home and i had the worst pain in my ankle, so they hauled me down to cath lab did another test and found the closure had went into my veins. it disintegrated. i was taken in for emergency surgery. they got some of it out but had to call the manufacturer to see how to get it out. well on Aug 23rd i had to go back for another emergency surgery to get some more out. i was in the hospital for 7 days and at home for 3 1/2 months with a home nurse coming every day. i had 3 or 4 infections in one of the cuts, which by the way are about 4 inches long each one. well today is mar 9th, 2010 and guess what. went to cath lab again and had 3 more veins done because the gunk from the mynx was in them. i have been laid up for months now and it has not been fun.
Roberta Lynn Henry, patient, Michigan, USA, March 10, 2010

• On Friday 26 February 2010 I had a cardiac catheterization at St. Lukes, in Milwaukee, WI. The procedure went off without a hitch, I did not experience pain in fact very little discomfort. The test result showed that I had no blockages in my heart nor did I require a single stent. We were literally done in five minutes… The doctor then applied the Mynx wound closure system to the needle insertion site. Result immediate PAIN; so much so that my breath was reduced to gasps between clenched teeth while on the procedure table. (Hurt like a %!#*)I requested pain medication and since the procedure, the discomfort is not getting any better. 1. Pain in lower abdomen, 2. Swelling of my entire right thigh leg and lower right torso. 3. EXTREME TENDERNESS in my groin, (did I emphasize extreme?) 4. I cannot sleep on either side or even urinate without discomfort. I have been off from work for an entire week (so much for the in by 06:00 out by 12:00 noon argument). Today is Tuesday 9 March and I’m still off work and sore as hell.
Bruce, Kenosha, Wisconsin, USA, March 9, 2010

• I had a heart cath. done 3 days ago. They used the angio seal to close. My potassium was low. I was given 4 bags of potassium before being sent home. The next morning I had severe pain at the groin site and down my leg. I had pain down the middle of my leg the next day. Tomorrow I go back to work at a very large hub. I am afraid I may end up in pain or pass out. The doctor said to give it 72 hours. I wish I had been given some info on this. Thanks.
Robin H., Louisville, Kentucky, USA, March 1, 2010

• Tammy from Ohio -- Vascular Closure Devices were developed to reduce complications from bleeding and to allow patients to walk sooner. They have done that, but they carry with them their own brand of complication -- small in percentage, but not if it happens to you. Consumers can report an adverse event from any device directly to the FDA -- http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Forum Editor, Angioplasty.Org, February 8, 2010

• My husband had a stent procedure done in November. He ended up with 4 drug coated stents. He is 47 years old and has bad family history, but otherwise in excellent health, active, eats well, and not overweight. We had one complication after another after the initial procedure. In short, the closure device used was blocking blood flow to his leg. This time he had to have a bypass to remove the closure device and a good portion of his artery as well because it was becoming diseased. Since this procedure in December his scar is still bothering him and the nerve damage is expected to continue bothering him for up to another 18 months! Why are these closure devices used if they cause such complications? Furthermore, if there are no negative consequences to the doctors or hospitals for complications where is their incentive to get it right the first time???
Tammy, Ohio, USA, February 8, 2010

• Karen from Michigan -- as you can read here, and counter to what you've been told, there ARE complaints (with over 500 postings, this Forum Topic is unfortunately one of the most popular on our site). Granted -- in percentage these complication are small -- most studies have shown complications in about 3-6% of catheter-based procedures done from the femoral artery. Are they under-reported? Some cardiologists think so. For example, do you think your experience has been reported as a complication? But don't be afraid for the next time. Discuss your experience with the cardiologist doing the procedure. Also look into getting the procedure done radially next time. There are an increasing number of cardiologists who use the radial artery in the wrist to do angiograms and angioplasty (check out our Radial Access Center). The advantage is much fewer complications, especially in overweight patients -- but only 5% of procedures in the U.S. are done this way because it's a relatively new approach and most cardiologists were not exposed to it in their training. And there is no need for a vascular closure device -- only a pressure dressing.
Forum Editor, Angioplasty.Org, February 4, 2010

• I had a heart cath done in Sept 08. I was immediately diagnosed with 2 blockages in my heart @ 95%, sent by ambulance to a larger facility to have angioplasty done, and after which they used a star close on my right femoral artery. I am over weight but never had any previous complications with the inner thigh (groin) area. I have more days than not with pain and at times it's hard to walk (maneuver) my right leg and hip. I have mentioned this to my cardiologist several times and he states he has heard no complaints. This is very disappointing and I am not sure where to go to find the answers. I am tired of living in pain and I have recently begun to have more symptoms of another blockage but out of fear of the heart cath and more angioplasty with the possibility of another problem like this one scares me to death.
Karen, heart patient, Michigan, USA, February 2, 2010

• On May 29th 2009 i had Star Close inserted in right groin, have been suffering since. having nerve damage checked soon. I too have most of those symptoms, very painful always, getting up from a sitting position,up and down stairs. So exhausted.
Doris F., California, USA, February 1, 2010

• Shelly from West Virginia -- one of the questions is whether or not these adverse effects are caused by the closure device (Angioseal, Starclose, etc.) or by a problem in the catheter insertion needle stick. There is also a Forum Topic on "Complications After Angiography" in which you can read many of the same complaints -- even when no closure device is used.
Forum Editor, Angioplasty.Org, January 29, 2010

• I had an angio seal used on me after heart catheterization on 10-05 05 ,i have the same problems with my leg going numb back hurts groin pain stomach pain .pain while walking foot goes numb leg pain. I had angioplasty done still the same her it is 2010. need to find out if any class action suits being filed for angio-seal st. Jude they need to stop using these seals on people and also get permission also to put in your body. I also have a hernia at the site.
Shelly, West Virginia, USA, January 28, 2010

• Angioseal uses bovine collagen. As to when you can work out, you should consult your cardiologist.
Forum Editor, Angioplasty.Org, January 28, 2010

• I had the angioseal placed on Jan. 11, 2010. No complications, but I'd like to know how long I should wait before I can workout. Also, I had collagen injected into my lips 10 years ago and it turned into hard balls of mass, instead of smooth lines. Is it the same type of collagen they use for the Angio Seal? If so, should I be worried.
Mari, Iowa, USA, January 27, 2010

• I had an diagnostic angiogram in Sept. 2008 and had a StarClose used to seal the femoral artery. Since then I have had frequent pain in that leg, starting from the site of the incision and radiating downwards. About 10 days ago the pain become much worse and is almost constant now. The area around the incision site is tender and the skin over it is very sensitive. I was diagnosed with Fibromyalgia in Sept. and don't know if that could be related to it somehow? It is flaring right now, but the leg pain started before the flare. Still worried that it has something to do with the StarClose.
Jenn T., Illinois, USA, December 19, 2009

• I'd like to give an update to my post on October 16 regarding the Mynx Vascular Closure Device. So I was officially diagnosed with a scrotal (testicular) hematoma. My cardiologist (and I believe his team) will not use this device again. I am under the watch of my urologist. Anyway, its nearly two months and things are getting better..but the healing process is slow. I'm probably at 85%. The discoloration is gone and the scrotal area is looking reasonably normal. The left side is nearly fine and the right side appears to still have blood that needs to be absorbed (my radiologist confirmed this). I have a visit with the urologist tomorrow and he will determine whether I should just give it more time to heal or whether a procedure such as a hydrocele would be needed. The biggest problem is that you are supposed to be exercising right after this surgery, but I was in bed for 10 days, out of work for 17 days, and overall, the first month was focused on just being able to walk without pain. I am now working out, and I'm hoping that be the end of the year, I will be "normal".
Lewis M., New Jersey, USA, December 7, 2009

• Tom -- The official FDA-required package insert for the StarClose states, "The safety of re-puncture at any time through any part of a previously deployed StarClose Clip, and the safety of subsequent closure of this re-puncture using the StarClose Vascular Closure System, have not been fully established." That being said, many cardiologists successfully re-enter the clip or re-puncture the artery, and there are a number of papers out there with details on these techniques. Since, like you, most patients who get an angiogram are likely to get another, a device that rendered the artery unusable for future procedures would not be very marketable. As for removing the StarClose, this can only be done surgically. But if it's not causing a problem, there's no reason to.
Forum Editor, Angioplasty.Org, December 6, 2009

• Please tell me that the StarClose device can be removed. I had one used on my femoral artery about 6 weeks ago. If I had known that it would be used, I would not let the doctor work on me. For the past 7 years, I've had either a stent or angiogram every 6 months and I need that access in my right femoral. The left femoral is 70% blocked so it can't be used and I'm not sure if the wrist or elbow can be used for the larger cath procedures, like my carotids. Right now, I would feel a lot more comfortable with future procedures if the thing can be removed.
Tom B., Out of luck, North Carolina, USA, December 6, 2009

• Jim -- Terrible tragedy and our sympathies go out to your and yours. A retroperitoneal hemorrhage is one of the most serious complications of a femoral artery puncture -- sometimes difficult to see because the blood fills the retroperitoneal cavity (which is quite large) and is not obvious until it has become a very serious problem. One question: was it documented that the cause of the hemorrhage was a failure of the Angioseal? The reason we ask is that the AngioSeal is on the front side of the artery and bleeding there, caused by a rupture, would be more obvious and sooner. What happens in a retroperitoneal hemorrhage is that when the access needle goes into the artery, it goes too far and it goes out the back wall, causing a backward bleed. Vascular closure devices only seal the front end and a puncture in the back is hard to diagnose. These complications, while relatively rare, are very serious and is one of the reasons we at Angioplasty.Org have been promoting greater use of the radial (wrist) approach, where none of these issues exist. Let us know any more details and, again, please accept our sympathies in the loss of your loved one.
Forum Editor, Angioplasty.Org, November 25, 2009

• My husband had a right lower extremity revascularization of the right superficial artery on Aug 7, 2009. They placed an Angio-Seal vascular closure in the left femoral artery. This was an outpatient elective procedure, in at 8 out by 2. Sometime during the middle of the night the seal failed producing a massive retroperitoneal hemorrhage. Blood filled the body cavities, could not breath and suffocated. He was dead less than 20 hours after the procedure. Has anyone had any success with St Jude on failed seals resulting in death. Any recommendations?
Jim M., Napa, California, USA, November 20, 2009

• On Feb. 25, 2009 I had a Perclose device inserted following stent placement and angioplasty. Within thirty hours I was found to have a 50% loss of blood flow to my right leg which necessitated emergency surgery to revascularize the femoral artery with harvest of saphenous vein. Needless to say I am now very concerned to ever have that procedure done again.
Leona H., Missouri, USA, November 20, 2009

• Update to previous post -- I saw a vascular surgeon he advised me not to get another closer [StarClose] device, he stated they are not needed. Had ultrasound of thigh, both star closer's seem to be properly placed. Surgeon feels the pain, swelling and numbness may be due to scar tissue around device. He said it CANNOT be removed, only bypassed which would mean they would have to take an artery out of my leg and bypass the area with the star close device. Seeing a neuro this week to evaluate for nerve damage. PLEASE PLEASE Report your issues with this to the FDA!! Using their adverse report online system ! it is confidential!!
CM, New Hampshire, USA, November 14, 2009

• Gale -- by "stent" in the way, do you mean the StarClose device? It's not a stent, and it shouldn't cause a problem with re-accessing the artery in the future. However, the numbness you feel may be the result of nerve trauma from the needle stick and catheter movement and may or may not be related to the vascular closure device. Also read the related topic on "Complications from Femoral Site During Catheterizations".
Forum Editor, Angioplasty.Org, November 14, 2009

• had carotid angiogram done October 2009, procedure went fine, ending with insertion of Starclose. When attached severe pain ran down leg to inside of right foot.[Twice] Tingled a lot and leg felt numb entire time was in recovery area About 1 hour, reported to doctor in procedure room and nurses in recovery area, no comment from them. Still one month later I have a numb sensation, all the time and a painful tingling at numerous times during the day and night, on the inside of my right foot and ankle. The skin is so sensitive, I cannot stand for the area to come in contact with even sheets on the bed. There is no external sign of a problem. Will the stent be in the way if you have to have another catheterization study? Will the tingling and numbness go away?
Gale V., North Carolina, USA, November 12, 2009

• T.J. -- Just so we're clear, the groin/leg catheter access site is via the femoral artery -- right at the groin, the crease where the thigh meets the lower torso. By "groin", doctors don't mean the scrotum or area in-between the legs. But you should know where the catheter went in, because you would have had a bandage and some healing going on there. So technically, the access site is the "groin at the top of the thigh".
Forum Editor, Angioplasty.Org, November 7, 2009

• I had a heart cath in sept 2009, around a week or so later I developed sharp pains in my leg at the groin site. In the next days to come I could feel the angio seal moving up and down and clicking as well. It was and still is very painful. Since then I 've went back to the same hospital. When I explained what was going on about the clicking and moving as well as the sharp pangs that I felt up and down my leg as well as the severe pain in my groin area the doctors reply was" the doctor that did the cath did not go in through the groin area, he went in through the thigh" he knew as well as I did that he went in through my groin area. That's how it was explained to me and that's the sight that they went in through. Now I have been to two doctors and they are trying to tell me that I don't feel what I said I do where I say that I do....but I have to go and get another operation tomorrow which is november 4th 2009. I just want to make people aware of some of the dangers of an angio seal. Now they say that I have a hernia which I don't believe right at the same site.also I caught pneumonia a couple days after the procedure. I am in severe pain as I write this. People please be aware.
T. J., Wayne, New Jersey, USA, November 3, 2009

• To all posters -- and we've written this before -- although they were invented to reduce complications from bleeding and to allow patients to ambulate (get up and walk) earlier, these device come with their own set of complications. However, some of the problems patients are posting here may be due problems with the catheterization itself (the needle stick, puncture of the posterior wall of the artery, resulting in a serious hematoma or bleeding complication, or trauma to the femoral nerve -- something which might result from a closure device, but more likely is from an off-the-mark needle stick or from catheter manipulation. We suggest inquiring as much as possible from your cardiologist. Also read the related topic on "Complications from Femoral Site During Catheterizations".
Forum Editor, Angioplasty.Org, November 1, 2009

• I had a heart cath done in the right femoral artery that was closed using the mynx closure device. First 2 days were fine but day 3 developed swelling, pain, and bruising on the site and especially in the groin area. I am a male so this made sitting, walking, and going to the bathroom difficult and painful. Contacted Dr.'s nurse ,she said this was normal as most people looked like they had been hit with a baseball bat.Is this normal? I also contracted a staff infection that was MRSA, spent a week in hospital for that hooked to a wound vac for 2wks.It has been 8 wks since surgery for infection (removed device while cleaning out wound)still have tenderness in lower ab and groin area.If anyone has had similar pain from any of these procedures or infections from using mynx or other devices let me know. The VASC. SURGEON said the infection came from the closure device.
KH, North Carolina, USA, October 28, 2009

• ok as others I also had heart cath.only 4 days ago October 19,2009 and was given the Angio-seal with out any information before hand. I woke up on the table with someone trying to so something and 3 other attendants came over something was wrong. A few hours after leaving the office immediately called dr complaining about the pain in the groin area which goes around to the lower back and numbness down right leg to foot. Unable to stand or sit and trouble walking. The Doctor ordered the tests necessary to rule out blood clots,but still have pain numbness . I went to my Chiropractor and got a little relief but still unable to sit or stand with out the pain. Not sure what to do next.No fever or bruising just the pressure. feels like the angio-seal is pressing on my nerve.Very sick to my stomach all the time.debi
Debi B., Florida, USA, October 23, 2009

• I am 53 years old and 4 days ago had an angiogram and as a result a stent placed in an artery that was 95% closed. The stent procedure went well, but the closure device has had serious and very painful results. My blood pressure dropped that evening to 65/35 and soon I was wheeled down for an ultrasound as my scrotum and lower body was turning black and blue. The device used was called the Mynx Vascular Closure Device, which is a sealing device. I was released from the hospital yesterday, and can not get around at all. My groin is in tremendous pain and my scrotum and upper thighs are significantly swollen, black and blue, etc. Because I am athletic ( a former marathoner) and in good health, I was told that I may have been the first person to use this particular closure hardware at this hospital, which is a leading cardio hospital in the US. Luckily I an able to urinate without difficulty. I have follow-up visits scheduled with my internist, cardiologist, and urologist. I've been told that the answer to my problem is time....does anyone out there have a similar story and is there hope that I will get back to my former self?
Lew, Bergen County, New Jersey, USA, October 16, 2009

• I have had an angio seal 18 days ago i have burning sensation in right groin calf aches like hell after two hundred yards walking on the flat and much quicker on a slope foot felt like it was on fire after playing tennis with very little running around -- kerry 49 uk
Kerry T., England, October 15, 2009

• My name is Anita. I had the catheterization done in Dec.23 of 2008. here it is Oct. 14, 2009. I am in a lot of pain, I have went back to the doctors many of times. and nothing is being done. I have went the nerve doctor, and he found nothing wrong. I've been put on pain meds, but they don't work. I have muscle spasms and everything else that everyone is saying. I did not know that this star close was a permanent thing. the doctor didn't tell me anything about it. it is hard for me to do my job. its hard to walk. I was told that I had a lymph nodes, and that it would go away. but the pain is still there, and getting worse. I will be looking into a lawyer. and if anyone else wants to join me, get in touch with me at anita.grant@comcast.net -- it's time that something needs to be done about this.
Anita Grant., North Charleston, South Carolina, USA, October 14, 2009

• I had a heart cath done on Aug 22, 09 and i ended up with an 8 day hospitalization and as of this day still have nurses coming to the home. i had the mynx closure device and which i didn't know i was getting. it dissolved upon placement and went into my veins in my leg. had 2 major surgeries on my leg and 3 heart caths. i haven't done anything in 2 months and have had 2 infections for which right now i am being treated for the second one. this has been horribly painful, my leg has majors scars on it nd i have been all around miserable. i was told after the fact that the odds of having this happen were 0.05%. has anyone else had this happen and what about suing. i was also told the drs couldn't get the gunk out and called the manufacturer and they gave them some ideas but didn't' have a protocol in place.
Roberta H., Michigan, USA, October 12, 2009

• DF -- The StarClose is a permanent nitinol clip and can only be removed surgically.
Forum Editor, Angioplasty.Org, October 10, 2009

• has any one found out if they can take out that Star close?
DF, California, USA, October 3, 2009

• I had catheterization done 3 weeks ago, no blockage was found just a couple of leaky valves doc said not to worry about. I have a angio seal in my right femoral groin area. three days ago I started having pain on the inside of my right leg and now walk with a limp, is this normal, will it go away in time. I am otherwise a very healthy 57 year old women.
Cynthia E., Phoenix, Arizona, USA, October 2, 2009

• I had a UFE in October, 2008 and they use a star closure on me without my permission. I am a registered nurse and I would have much preferred to lie flat on my back for 6 hours then to have endured the pain from just the insertion of the star closure. First of all, being unaware the device was being inserted, it was more painful then the entire UFE procedure. It has been a year, since the procedure and I have had right leg/hip pain and numbness consistently, especially, when I do certain exercises or sit for a while (like driving). The patient needs to be given the option for a star closure and I was not give the option. I am for sure I would not have chose this option. I hope the device is being evaluated and patients are given the option and know the risk and side effects. I pray my right leg doesn't get any worse over the years.
Cassandra B., North Carolina, USA, September 22, 2009

• I had stent implants in April 1998, July 1998 and August 2009. All three were by the same doctor. The first one was done with the "angio-seal salesperson" in the operating room and worked fine. The second and third angio-seal did not perform at all. A nurse had to hold her finger in the"hole in the dike" for hours to stop the bleeding and on the third one I got the sand bag treatment for the night.With four by-passes and three stents since 1982 I think that should I need another stent I will request that your sales person be in attendance. Any chance of getting my money back on the two that did not perform as advertised?
Harold B., Colorado, USA, September 22, 2009

• I just had my second angioplasty and stent placement; the first time being in February 09. Stent and angio in left leg, 2 angio balloons in the right leg. The right leg did not fare well, so last Thursday (9/17) I had the left stent angio'd again, and a new stent placed in the right. I feel great. I have posted here before regarding the Starclose issue. This time, I was made to lie flat for 12 hours - 6 hours after the angioplasty, direct pressure on the groin was applied by the nurse for 20 straight minutes, and then I lied flat again for 6 hours. Not fun, however, the incision healed beautifully. As happened the first time, I have a rash in my lower body and am wondering if it my body's way of reacting to the stents?
JL, Waltham, Massachusetts, USA, September 21, 2009

• I had the Starclose device implanted after a heart cath.in 2006. I have had no complications. However I was 45 at the time with "wide open" veins. Now I have a piece of metal in me for the rest of my life, put in without my knowledge or consent. Now 3 years later I have autoimmune disease(s). IS THIS A COMMON OCCURANCE? I have to have a MRI and they are hesitant to do one! What does this say??? After surgery the hospital couldn't give me much information on future problems, because we are the Guinea pigs. I was told to contact Abbott Labs. How truthful are they going to be? On my paper I carry around in my purse it doesn't give a number , how does Abbott Labs keep track of the after effects or adverse reactions???
Amy, Erie, Pennsylvania, USA, September 7, 2009

• I read all these people in pain due to star close Any one got any results and fixed it. Any one removed it. I am in pain and need advise what should I do to get rid of it.My angio was done last year in Nov
Mike S., Redlands, California, USA, September 3, 2009

• I had Angio graphy done in Nov09. Since then I have complained my Cardiologist Dr. Slayah many time that I have femoral and Groin pain. He said he has never heard in his practice someone to have pain due to star closer. I am so much pain that I can not take it any more. It's affecting my relationship. What can I do? Please advise. Dr is simply in denial that this is the cause of the pain.
Mike S., Redlands, California, USA, September 1, 2009

• I had a heart cath performed on June 23, 2009. The surgeon used an angioseal. I am still having pain in the groin area, shooting into my right leg. Is this normal? I was told the seal would be dissolved within 60-90 days. I still cannot touch the area where is was used.
Patti D., West Virginia, USA, August 27, 2009

• I had an angioplasty done day before yesterday and i have very little if any bruising in my groin. They reopened a blocked subclavian artery in my left arm last oct and closed it with a starclose devise. This was also done the other day Aug 24th 09 so i was under the understanding that these dissolve after a few months. It is sounding now like they stay there. I have 2 in the right femoral artery and I now have intense cramps on that side along with chest pain in the center of my chest and throughout my stomach. as though a metal clamp is compressing my internal organs. I am experiencing headaches and pain as i walk. Should I be concerned of a blood clot forming and moving to my heart? I have high blood pressure and I just want to be well again. Does anyone have these symptoms and do you think i should call my dr.?
LeAnne, Twisp, Washington, USA, August 26, 2009

• I am a 47yo nurse.In April,2007 I had a cath/PTCA/Stent and was closed with Angioseal. After 2hrs of bed rest I walked in the hall and was fine. I got up the next morning to shower and experienced a severe burning sensation and pain in my groin. I had developed a huge bruise from lower abdomen to mid-thigh. My cardiologist was contacted immediately and I was on 4hrs of bed rest with a sandbag.He discharged me that afternoon. After getting home, my leg was heavy and my calf cramped unbearably walking 100ft. My cardiologist brought me in and ruled out blood clots. 2wks went by without further improvement so he brought me in for arterial dopplers which also proved normal. Again,after another 2 weeks and no improvement he performed stress dopplers which showed very little blood flow. He immediately scheduled an angiogram with run-off that revealed 100% blockage to anterior, posterior tibial and peroneal arteries. All due to Angioseal shooting down my leg. This led to an overnight in CCU with Urokinase and repeat angiogram/stent.They were unable to open the ant. tibial and peroneal. So,I continue to deal with pain and now the stent is closed. I'm having another angiogram on 8/28.
Debbie H., Alabama, USA, August 26, 2009

• I had a cardiac cath done in approx. 2005 or 2006. Have developed pain in in groin at the puncture site steadily increasing in level over the last 2 yrs. They did use a Star closure device without my knowledge. I am a nurse and began to search for answers and found this site. Is it possible to electively remove the device without major surgery? The persistent ache and heaviness of the right leg makes working difficult.
rlf, Torrance, California, USA, August 25, 2009

• MK -- we hate reading stories like yours...where a vascular closure device caused a serious complication. Again these are a small percentage, but they happen. It's one reason we have been promoting the radial (wrist) access site on Angioplasty.Org -- which has been shown to have fewer complications and uses no closure device. No method is perfect, however. You might want to consult with an interventional cardiologist or radiologist, specifically one who is experienced in placing stents in the peripherals for a second opinion.
Forum Editor, Angioplasty.Org, August 19, 2009

• It has been over 2 years now & I am very concerned about the starclose device I have post cardiac catheterization After reviewing carefully all information regarding this device, I would like to know why patients are not being asked if they have any metal allergies. I have a reaction to nickel. In the last 2 years I have gotten several rashes, chronic fatigue, and the severe pain, spasms of my femoral artery are very intense at times. I truly do not know where to go for advice. I noticed one person said they had an MRI. Would that indicate if there is a problem with the starclose? Anyone out there know if this device can be removed?? I was told I had clear arteries at the time of my heart cath, but now with all these issues, I wonder if plaque isn't collecting on this foreign object in my artery causing occlusion & or spasms of the artery.
Graham, West Virginia, USA, August 13, 2009

• David -- while it may be the StarClose device that is causing the nerve problem, it may also be that the nerve was traumatized/injured during the needle stick and catheter procedure. A number of patients in this and our Forum Topic on "Complications from Femoral Site During Catheterization" report similar nerve problems, not limited to procedures where the StarClose is used.

We at Angioplasty.Org agree that these types of problems, and vascular complications in general, are significantly under-reported. And prominent cardiologists agree with us. Part of the problem is that once people leave the hospital, or the cath lab, problems they may be having are dealt with by a general MD, or the ER, or a vascular surgeon, and the feedback about complications often never gets back to the interventional cardiologist, let alone the FDA. One thing patients can do is to report complications directly to the FDA. Another is to look to practices where the radial (wrist) approach is used. Complications, especially bleeding complications, have been shown to be far lower when catheterizations and procedures are done via the wrist -- the problem is that few U.S. cardiologists use this approach. By the way, angioplasties done via the wrist need no closure devices -- hemostasis (bleeding) is stopped by a simple pressure band. As for complication rates reported by the companies, these are based on the initial trials that were used to get FDA approval for the device. In the case of the StarClose, that trial consisted of a total of 208 patients. For more information, read the FDA Approval Letter from December 2005.
Forum Editor, Angioplasty.Org, August 13, 2009

• Update for David Newton. Based upon the placement of the Starclose device being in close proximity to femoral nerve, there is no doubt to me that the 3 mm disc is causing intermittent impingement upon my femoral nerve. This has caused severe pain and numbness down the inside of my right leg to varying degrees. I have an appointment with a vascular surgeon next week for a consultation. I recently saw the cardiologist who placed the device who stated that it was impossible for the Starclose disc to be causing a nerve problem. I referred him to look at this Web site before he made any conclusions.

Here's the problem: The main complication in the literature is vascular injury. This is frankly a obvious objective finding and can't be ignored. It must be reported.

Our problem: Pain is a subjective finding and can easily be dismissed. Therefore it can be omitted from the complication data reported by Abbott labs.The post procedural pain IMO is being ignored (like mine was) and as a result is not being reported. The only other plausible theories for persistent pain are local sensitivities to the nickel/titanium alloy causing an inflammatory response. I WILL FIND THE CAUSE!
David Newton DC, St. Joseph, Missouri, USA, August 12, 2009

• Had two angiograms done, both used Star closer [StarClose] devices. Everything was great for 2 months. Now I am having sharp pains in my artery in my groin area. Foot goes numb, and I am having muscle spasms in my leg.
CM, New Hampshire, USA, August 3, 2009

• Gerri -- product and safety information for the StarClose can be found here on Abbott's web site. Most of the information you might want is probably on this page. The main reason for the card is to let a possible future cath lab doctor know that you have a StarClose clip (it's permanent). As the web site states, "The safety of repuncture at any time through any part of a previously deployed StarClose Clip, and the safety of subsequent closure of this repuncture using the StarClose Vascular Closure System, have not been fully established." If you want a card and pamphlet, we're sure that Abbott Vascular would be happy to supply you with them. You can call the division at (800) 227-9902.
Forum Editor, Angioplasty.Org, August 2, 2009

• I had a procedure 3 days ago and the doctor used the StarClose Device. I haven't had any problems, but the nurse did not give me the pamphlet & card that I'm suppose to have. How important is it that I carry the card and how could I get a replacement?
Gerri D, Tennessee, USA, August 1, 2009

• well, as far as i know the clot that i had was there before i went to hospital, that's what my hubby said, i have very little info on all the hospital stay, as a matter of fact they sent all my records to another facility that i had never been to even tho i had told them where my records were twice,so not only did i have to deal with all the extras with the pain and suffering, i had to tract down medical records that i might need for a later date, omg what a journey this has been, my lab result were i need to increase the med for the clot, this i got on my own after a nurse at a clinic i use was kind enough to read it for me this has been a roller coaster ride for me when i had the cath done the doc, came in about 5 hrs later and said i can go home he said that medicare didn't like patients to stay longer than needed well were tircare and his comments were rude and not welcome by me or hubby who served in the army for 27 years now i will schedule a appt with the clinic that i do go to and just go from there the closure still bothers me in the groin area. i don't know about the metal that they used only time will tell what i need to do good luck to us all.
Terri, Batesville, Arkansas, USA, August 1, 2009

• I had my second heart cath done on 4/13/09. I clip was used without my prior knowledge. Yesterday I noticed it was tender in the area and is getting worse all the time. The doctor's office says go to the ER, etc., if it gets worse. Sure...Let's hope it goes away on its own. Have any of you sued or had your cardiologist to cover the subsequent expenses from their mistakes?
LRS, Tennessee, USA, July 29, 2009

• Terri (et al) -- we recommend readers to also check out the "Related Topics", especially the first one "Complications from Femoral Site During Catheterization" -- some of the problems described below may not in fact have anything to do with the vascular closure device, like Angio-Seal, StarClose, etc., but may be complications from the femoral access site or the procedure itself. Terri -- were you informed that your blood clot problem was related to the Angio-Seal??
Forum Editor, Angioplasty.Org, July 26, 2009

• hi there i had angio seal placed in my thigh after a heart cath was done here's how it was explained to me the doc will use this or this and if you're lucky he'll use this and you will not be flat on your back for hrs..well how wrong were they next day when getting ready to leave the hospital passed out and they barely found a pulse (this was from the pain) was so severe i was in shock was put back to bed , they found a blood clot in my right leg below my knee they say not large but enough to put me on blood thinners and stay another 5 days, wow so much for that procedure getting me out the hospital fast my blood pressure was high the whole time i was there another reason they kept me finally after my release and the doc. telling me there will be nothing to worry about and i can resume normal duties at work and at home..well this hasn't been the case i was admitted on the 18 for extreme high blood pressure and they did the cath to ensure that my heart was ok now that i am home things are terrible i can barely walk the pain is unreal and while i was going thru my papers that's when i found the paper with the procedure that i had done, wow something that was suppose to get me out the hospital done just the opposite now its the 27 july and i an taking pain med and was advised to return to the doc to get checked out this stinks i raise two grad kids children and don't think i will be able to return to work soon. I have a very good boss so i don't have to worry still we need to have more choices not the doc.
Terri, Batesville, Arkansas, USA, July 26, 2009

• I had a uterine fibroid embolization on July 1, 2008. I had normal/tolerable pain right after procedure. This device was also used. Had no problems until about 1-2 months ago (almost at one-year mark). Now I have pain in my right leg/groin. At night when trying to sleep with legs bent, I can not. This is when the pain is worst and I have to stretch my leg out to sleep. After 2 back surgeries, I sleep better in fetal position with my knees bent. No longer able to sleep well. :( Seeing the Dr. again 8/4.
Carol S, Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, USA, July 23, 2009

• Update for David Newton Please read my July 14th post first: I had an MRI done on July 18th 2009 with and without contrast. The results concluded that the Starclose device was placed too far laterally in the femoral artery and was in close proximity to the femoral nerve. There is now no doubt as to the cause of my persistent leg pain. I can think of only one solution though and that would be costly vascular surgery. I can't believe the cardiologist placed this foreign object into my body without any prior verbal disclosure. I received a pamphlet only after the procedure was done. This IMO is clearly a violation of patient rights.
David Newton DC, St. Joseph, Missouri, USA, July 21, 2009

• my sister also had an angioseal in her left groin. it detached and was found down her leg after 2 weeks in the hospital. she had a surgeon remove part of it and now 8 months later is having the same problem. they are not sure they got the whole thing out and it lodged in behind her knee cap. this is the third operation and she is still having a hard time walking. nobody has any answers.
Linda, New Jersey, USA, July 21, 2009

• Had second angioplasty on July 16 with AngioSeal to close...first time having a device and last night had a electric shocking pain that it jolted me in the bed. The pea size knot is there, but I can also feel the length of the seal...is that supposed to be? Also, I walk with a little limp on the right leg (where the device is located) and wonder if it slipped out of place (?) Any advice will help, thanks.
YS, New York, USA, July 21, 2009

• my seal has been a year ago through various doc's (I forgotten about the actual seal) now have narrowed it down to the seal, the Dr.'s office won't talk to me personally?! about any complaints. I'm at a loss.
Kelly, Gilbert, Arizona, USA, July 16, 2009

• Hello, I had an angiogram done in October 2008 and had the Starclose device placed. When it was time to get up in the recovery room, my whole leg was numb and stayed that way for several hours. As the numbness went away pain developed and was severe down the inside of my leg and thigh for several weeks. The doctor ordered a sonogram to determine whether I had an aneurysm of the femoral artery. I was upset in the first place because I have an autoimmune disease and would not have consented to a foreign body implant. I thought the problem would go away as I thought they had probably stuck my femoral nerve with the local anesthesia and when it persisted I then thought perhaps they nicked the nerve with a scalpel. But now I'm absolutely convinced that the Starclose disc is chronically and intermittently impinging upon my femoral nerve. Many times foreign objects will develop scar tissue and enlarge over time. That 3mm disc could now be a 5-6mm scar tissue ball. The only option I know of is to consult a vascular surgeon. It may be remotely possible that ultrasound could help with pain but not entirely likely. Even a lidocaine patch may work as well. I might try that....It has been 9 months now and today I can't walk because of an acute "attack". This is the worst in a long time. So it is evident that this complication is not going to go away. As a result I called the surgeon's office and I'm going to ask for a CT scan to see what's going on. Good luck to all of us! We will need it.
David Newton DC, St. Joseph, Missouri, USA, July 14, 2009

• I need help. My wife had an arteriogram done last year (June 2008) related to an AVM in her brain. The last few months however she has been in searing pain which has kept her up or affected hr in other ways. She has had ultrasounds done by her general doctor but those have shown nothing. The surgeon who did the procedure has not returned any calls yet and we are worried. After reading some of these posts I wish the doctors would have been more forthright about this. If I knew the type of complications my poor wife would be having I would have forgone this procedure. Any advice is helpful. Thanks.
Shooter Man, Arizona, USA, July 14, 2009

• I just had my catheterization done yesterday. The StarClose was used to seal my artery and today I went fishing, played a little badminton with the kids and took a short hike. All of this was done carefully, slowly, and with the doc's permission. There was no pain associated with any activity and I anticipate a full return to work with no restrictions after my follow-up appointment on Monday. As far as I'm concerned, the StarClose device worked perfectly.
Andy, Pennsylvania, USA, July 9, 2009

• Mike -- Good questions. The StarClose device is a small nitinol (nickel-titanium) clip which grasps the outside of artery slightly to achieve hemostasis (stopping of bleeding). Nitinol is a metal which does not degrade so it is there permanently. It's on the artery itself, so it is under the skin. You can read more and see a photo here.
Forum Editor, Angioplasty.Org, July 9, 2009

• I had angioplasty 2 weeks ago today and the artery was closed with a StarClose. Everything went extremely well and I'm having no problems at all. I'm merely curious as to what happens to the Starclose device? Does it get enclosed by scar tissue? Does it deteriorate or stay intact? Can it come loose? I can't find this info anywhere.
Mike Henry, Somerset, Kentucky, USA, July 9, 2009

• Anyone who has had a vascular closure device placed should bypass his/her family doctor, bypass his/her cardiologist and seek a vascular surgeon for evaluation. The statistical likelihood that there will be a complication is likely to be greater than 10% and this contradicts what doctors and websites will tell you. If you are feeling poorly in a matter of days to weeks after angioplasty should go to an emergency room. Anyone contemplating angioplasty should tell the doctor they do not want a vascular closure device and ask the doc to chart that in the medical record. For decades a nurse holding pressure with sandbags and bed rest have been safe & effective when the nurse is diligent. A vascular closure device is just another way to tag $500-$600 onto your hospital bill.In theory, the vascular closure device should make it possible to leave the hospital or outpatient clinic earlier safely without risk of bleeding, infection or other. It is not worth the risk, and I would not advise my family to have one used. Go to the FDA MAUDE database to read more about complications (adverse events) with vascular closure devices.How do I know all this? I'm a nurse who was fired for truthfully reporting too many adverse events that occurred after vascular closure device use.
Temporarily Anonymous Nurse, Winston Salem, North Carolina, USA, July 5, 2009

• I had a diagnostic angiogram in April. At my appointment prior to procedure, I specifically asked exactly how it was done, how they closed artery and even how the 2% complication, bleeding, was addressed. My dr. said that, other than the sandbagging, complications would be surgically sewing the artery to stop loss of blood and that since I'm thin wouldn't be an issue. I was specific about having nerve issues from previous inguinal hernia repair and having to have those staples surgically removed to release the nerves that were pinched. During the angiogram, I was not sedated, there was NEVER mention of anything until the stapler popped the Starclose into my groin. The pain was bad enough to make me scream and I've always been tough. The pain since has been bad enough to interfere with my daily life. I'm worried that I'll need to have it removed to save the nerve that was apparently pinched. But, if I have that done, am I taking even bigger risks with my life than dealing with the pain? My dr. is saying that the closer was a favor so that patients can go home quickly. I'm very sure that it was a time saver for him and his staff and that he didn't disclose it so that I wouldn't refuse it, which he would be right in assuming. I hate that I'm living my life differently now because of my doctor doesn't think it's a problem and won't take responsibility. I'm also worried about what they WON'T tell me. What is the truth? I'm 54, raising my grandchildren and can no longer just do what I want because I'm in pain. I really don't know where to go from here.
Teri Stewart, California, USA, July 5, 2009

• I have the Angio Seal and unable to peel the dressing off. Sounds stupid I Know but how do you get the clear adhesive started and then peel off? I can't get it started.
Richard Shaffer, California, USA, July 3, 2009

• I had an angio-seal inserted about two weeks ago. I have progressively had more and more pain in my right calf and thigh. I am not able to do any kind of exercise. Is this normal or a problem?
Jennifer H., Colorado, USA, July 1, 2009

• I had a heart cath done on 05/28/09 and the angio-seal was placed in my femoral artery and I have been in pain every since. The day of the procedure I was in so much pain as they tried to get me to walk just 2 hours after the procedure. It's going on 4 weeks now and I still can't get back to my normal active self. I have electrical shooting pains in my thigh and groin area, and at time a stinging pain at the groin site. I can't stand or walk as usual, It hurts daily. I'm going to the doctor in the morning. Will post what they tell me.
Kim S., Columbus, Ohio, USA, June 22, 2009

• I had a thrombosis of the subclavian artery on my left side affecting my left arm. On March of 09 they went in and put three stents in, going through my right groin and left radial in my arm. Arm seems to be doing fine as far as where they went in, arm still isn't any better though since they cleared blood clot. Where they went in through right groin I had a huge hematoma, almost immediately coming out of procedure, went across stomach and down right leg, had to be sand bagged for hours and hours, then they made me stay overnight. Have had nothing but problems with site, didn't even know until two weeks later when they did another cath through this time right arm radial, that they had used star close and at that time gave me a brochure on it. Its now June, it stings and burns and is very painful and for no rhyme or reason bleeds, forcing me to keep a bandage on it most of the time. I've told my cardiologist almost from day one of the procedure of all my problems, but he just seems to say oh it will be okay in time. I don't believe them, and now am scared to death and don't know what to do. Please, Please if anyone can help me, let me know. jirwin59@peoplepc.com Thank You for this site, I'm in disbelief and horror of all the things I'm reading.
JoAnne Irwin, Mexico, New York, USA, June 20, 2009

• I am 42 years old had a catheterization 2 days ago with angio-seal was used doctor never gave me options and just handed pamphlet to my husband after procedure i have many allergies and autoimmune disease doctor did not read my chart in pamphlet it states if you have this disorders that doctor should be aware before using angio-seal i now have severe pain in groin area going down the front of my leg along with numbness and can't walk and i am on pain killers ultrasound was normal and er doctor had no clue what this device was all about is this device used to save time and money? i will pursue to get more info from doctor who did procedure 5-29-09 has anyone have a specific answer or gone through same experience?
LM, New York, USA, May 31, 2009

• I had two Angio seals installed in right groin 3-11-08 and 4-24-08. Last five months my right leg is hurting and loosing range of motion, can't cross the leg or put on my socks. I need information. I mentioned to my primary care physician and he gave me anti-inflammatory. Anyone else have same problems.
Sam E., Choctaw, Oklahoma, USA, May 10, 2009

• WHAT IS THE TIME LIMIT (SAFE) AFTER HAVING AN ANGIO-SEAL IMPLANTED FOR A PERSON TO HAVE SEX?
A.D., Ohio, USA, May 8, 2009

• i am a 44 year old man that had an arteriogram a week ago. A starclose device was used. I have had severe pain at the site and i can feel the device right under the skin. Does this pain go away with time or should I be concerned? Has anyone else had this problem?
John S., Brierfield, Alabama, USA, May 8, 2009

• I am two days post op from cardiac catheterization with a Mynx closure device. Doing great, only minimal pain yesterday, no bleeding or oozing.
Jane F., Arcadia, Louisiana, USA, May 7, 2009

• I underwent angioplasty on 4/30/09 and am thrilled with the results. However, I am not thrilled with the Angio-Seal. Here it is 6 days post-surgery and the pain, while not severe, is uncomfortable at the seal site. I can't even walk around the block without discomfort in my right groin area. If I put pressure on the site, the pain is reduced, much like the relief one experiences when using underwear that put pressure on a herniated area.
David C., Los Angeles, California, USA, May 6, 2009

• I'm 21yrs old and I had a starclose put in a year ago and I'm still getting a lot of pain in the area of my starclose. My leg will randomly swell up, get red, and feel hot to touch. Every time I go to the ER they do an ultrasound but they can never find anything wrong. I'm just wondering if anyone else out there is experiencing the same problems. I also have problems with it hurting when it gets really cold too.
Fiona, California, USA, April 30, 2009

• I just had a diagnostic heart cath done on Monday 4/27/09. I have not had a negative effect as yet to the Angio-Seal, other than raised blood pressure, but it seems to have leveled off to an acceptable level. I am concerned however that I am required to carry a card stating that I had this procedure done. That concerns me. 90 days is a long time. What can I or can't I do after this procedure that I've not been told about? I refrained from driving the two days they say. NO baths for 5. No lifting 10 lbs or more for 2 weeks. That pretty much sums it up. I was given Versed before the procedure, so if anyone discussed anything else with me, I sure don't recall it.
Yolanda, Alabama, USA, April 29, 2009

• I am having severe pain in my thigh and groin after an angioplasty two weeks ago. A venous doppler scan ruled out blood clots. Pain medication just makes me sleep and I am still in pain. I see that several people have written to your forum about similar problems. Has anyone found and answer to the problem?
Karen F., Chicago Illinois USA, April 29, 2009

• Phillip -- a very small percentage of people are hypersensitive to bovine collagen, which is the active sealant in Angioseal. You might want to check with an allergy specialist if this might be the case.
Forum Editor, Angioplasty.Org, April 9, 2009

• I had the angio seal device put in after an arteriogram on March 5, 2009. ever since then i have had hot flashes and body sweats. i do not run a fever but i feel hot inside everywhere. can this be a side effect from the angio seal?
Phillip H., Gallatin, Tennessee, USA, April 6, 2009

• This is an update to my post on March 12 regarding the starclose apparatus sticking out of my skin. I went to the surgeon and the explanation was that the skin is supposed to grow over it; it then disintegrates over time. The surgeon believes that since I am thin and don't have a lot of excess skin in the area, it didn't heal over it as it was supposed to. The surgeon ended up yanking it out of my skin - ouch - and the area has now fully healed.Also, the lumps in the groin area have gone away. I was told they were lymph nodes that may have been enlarged and part of the healing process. Yesterday I had another pulse volume recording test, and my right leg did not do very well. Back for angioplasty I go at some point in the future.
JL, Waltham, Massachusetts, USA, April 4, 2009

• I had an Angio-Seal inserted on January 14, 09. I had significant bruising and indications that blood was trapped in the tissue, It was sore and had the knots that protruded. I had pain in my right leg where the device had been installed. I am experiencing significant blood flow loss to my right leg. The pain is from inadequate blood flow to support walking any distance. A second angiogram performed and appears as though a string has reduced the maximum size of the artery to about 1/2. The blood flow reduction has been confirmed with doppler flow and I am scheduled for surgery to go in and see what is or has happened and return normal blood flow to the right leg. Walking with reduced blood flow to the entire leg ia painful as ling as you are walking, but ease soon after sitting.
Don, Retired- 75 years old , Friendswood, Texas, USA, March 24, 2009

• I am an Insurance Administrator-my client submitted a claim with a Discharge DX as "Post catheterization complication occlusion of right femoral artery, status post surgical removal of foreign body - Angio Seal - Should the Insurance be held responsible for payment of this expense?
A. F., Bahamas, March 24, 2009

• i been home 3 days from angio seal I am in sooooooo much pain, I look like I am 10 months pregnant I ache all over and hard to walk and I feel so full I never ever hope ANY One gets this done! This is the WORST Thing I ever did in my life! Headed to the ER.
V., Arizona, USA, March 21, 2009

• Having not been advised of Starclose before cath other than a pamphlet -- would have never agreed to it. Informed consent is a part of patient's bill of rights. Any lawsuits because of physical harm?
Michele, Florida, USA, March 16, 2009

• I am a 30 year old extremely fit male whom has a venous malformation on my right foot. In order to find the extent of the malformation I underwent a arteriogram on 3/9/09 in which Dr. went into left side of groin into right femoral artery. I was closed with the Angio Seal device. I was in extreme pain two days following the procedure. It has been a week and I can't stand up straight as I have a very uncomfortable feeling near where the insertion was made. It feels like a lot of bloating or the pain you feel when one holds there urine for long periods of time. Is this normal as it has been only a week, or is recovery time normally faster. I can't return to work, I work in Law Enforcement and it hurts to walk not to mention run or move to quickly. I can't stand up straight due to the pain in the lower abdomen and top of groin. There is no visible bruising just uncomfortableness. Someone please help. I want to get back to work. The Dr. never told me about a Angio Seal and I think it was done to expedite time seeing as though the Dr. was hours late; and I was originally told that I would have to lie still in bed for several hours.
Dwayne, Maryland, USA, March 16, 2009

• JL -- that's something we've haven't seen reported on this Forum before. Please update us when you find out more from the surgeon.
Forum Editor, Angioplasty.Org, March 15, 2009

• I am a healthy 45 year old woman who had vascular angioplasty in both legs along with a stent. It has been 3 weeks since surgery, and today I noticed what I thought was a scab at one of the incisions, is apparently the StarClose sticking right out of my skin. On top of that, on both sides of my groin where the incisions were, I have almond sized lumps in the area. I'm wondering if exercising had something to do with all of this? I am going to the Surgeon tomorrow, but can not believe I was told nothing about this "StarClose" other than the yellow-type-sticky that was placed on the incision after surgery. What are they going to do, have to remove it since my skin didn't heal over it? The thought is making me sick.
JL, Massachusetts, March 12, 2009

• I am a 52 year old female. I had a catheterization done three days ago, which was clear, this was closed with an angio-seal. I was not told before hand this thing would be in me for 90 days. I have has some discomfort and pain on walking and the first night a bit of a fever. The discomfort is not so bad now but I am still concerned about this thing in me for 90 days. Should I still be careful with what I do,can I go back to work my job entails me standing for most of the day.Can it dislodged during this 90 days? I really think you should be told more about the after effects and after care and yes I did ask and was given a piece of paper with a few guide lines on it. Nothing said about the pain when first walking!!!
Janet T., England, February 19, 2009

• My Dad had the angio seal placed on Feb.12, 09. He was not told about it or given a choice. I thought it was a good replacement for the manual pressure. However after reading all the comments, when he goes in for his ablation, I will be sure to ask what the other options are.
Jeanne J., Wisconsin, USA, February 17, 2009

• In response to Maureen T. I hope your numbers regarding your friends hypertension is a type -o, 210 over 200?? As for why hypertension is a contraindication, any patients b/p must be under control,(most hospitals have there own guidelines) prior to pulling the sheath from the artery. The higher a patient's blood pressure is exacting force on the puncture site, the harder the bleeding would be to stop, or control. Usually on call meds are available for someone with hypertension to reduce the force on the arterial wall prior to pulling the sheath.If a patients blood pressure remains uncontrolled, better control of the artery and reducing bleeding is usually best obtained by direct manual pressure or by another device called the fem-o stop. In the opposite circumstance, medications are available if the patients blood pressure should be too low as well. Fluids and or meds could be given to help obtain a more stable pressure prior to sheath pull if the pressure is too low. I hope that helps.
M.G., Registered Nurse, West Virginia, USA, February 8, 2009

• Just a reminder to readers -- if you look through this topic and the related topic on "Femoral Complications", you'll read a number of stories that might make you too afraid of a very widely-used procedure. Just remember that this Forum is, by its nature, the "Complaint Department". People seldom write in to say, "I just had a cardiac catheterization and it was wonderful!" But if they have a problem, they go to Google and wind up here!

Yes, there are complications with any medical procedure. In this case serious complications are in the very low single digits. However, less serious complications or discomforts that are important to the patient also exist, as evidenced by this Forum. If you are having a problem, getting an answer from the doctor that there is nothing wrong might make you think you're imagining things (it's in your head, not your leg!). The reason for this Forum is to support your self-knowledge, but hopefully not to scare you. For some perspective, read this excellent post from M.G. in West Virginia from someone who has had a problem, and has good advice.
Forum Editor, Angioplasty.Org, February 7, 2009

• Hello my name is Misty and my mother in law has had an Angio-Seal done back in August 2008. I am now concerned for her well being. I have read about these complications which are similar to hers. I am wondering if someone out there can give me a update on the current symptoms , if they worsen or are new ones. Possibly found relief??????? Please send feedback. Thank you.
Misty, Columbus, Ohio, USA, February 7, 2009

• I had an angiogram about 3 weeks ago and also had an Angio-Seal closure. I have had no difficulty with it until the last few days. It is not painful but there is a little "picky" feeling at the site. No bruising. Just this sharp on and off impulse at the site. Cause for concern?
Van, Illinois, USA, February 4, 2009

• I had an angiogram in October 2008, I was in so much pain for 2 months and complained to my doctor about this. Finally, he sent me to have a ultrasound and was told that there was nothing wrong just my lymph nodes around the sight were swollen because of the poking around. I also had a low grade temperature for about a week. Well, its now February 3, 2009 I'm writing this still having pain not as severe, but it interferes with relations, walking or crossing my legs. I worry that the thing may cause more harm than my TIA did.
Y.N., Michigan, USA, February 3, 2009

• I had my tenth angioplasty 1/2/09 during which an angioseal was inserted. Because my angina did not resolve I was kept in the hospital and on 1/5/09 I felt a small "pop" in my groin, then a big "pop", called the nurse who called a "code". The next I knew one of the cardiologists (fortunately this was during"rounds") was applying pressure to my groin, I was introduced to the vascular surgeon who would repair the artery and we were speeding to the O.R. Two more weeks in the hospital and several transfusions later I came home but still need nursing care, I was able to live independently before this incident. I hope I can once again. It is now 2/2/09.
EL, Maryland, USA, February 2, 2009

• This is my second post regarding the Starclose closure device. I have read several if not all of the posts and posters need to know that there are several ways of securing the arterial site post cardiac catheterization or angiography/arteriogram. Starclose is the type of device used after my negative cath in 2007 and in which I posted in May, 2008. After my deployment of Starclose device I had excruciating pain for a year. My right groin site is now tender but tolerable. Most days i don't even notice it as still being tender but it is still noticeable on other days. Having said that, I must tell you that no procedure is without risk. I have every confidence in the cardiology group that did my procedure. I was just a little dismayed at first when I found out that the starclose, unlike angio-seal or boomerang procedure, or the Syvek, chitaseal patch that are only temporary: the starclose remains permanently in the artery and it only makes sense to me that it could potentially create an area of occlusion in an otherwise normal artery. Having said this, as I read others posts who say they are afraid to continue with angioplasty even though they have 100% blocked arteries, I have concerns that people are not going to receive appropriate interventions due to fear. I would just like to say, communication is the key and no matter how hurried you are to get the procedure over with or how busy the Dr. is, make certain all of your questions have been thoroughly answered prior to consenting. I do not regret having had my heart catheterization and I must accept my responsibility in the process of patient care. I should have asked for a time out to think about this new procedure (starclose) before I consented to it. I hope no one reading this will delay important treatment due to fear. Ask questions and DEMAND your answers before you sign. Thank You.
M.G., Registered Nurse, West Virginia, USA, January 15, 2009

• Debra -- the bruising is a hematoma -- bleeding under the skin. It's usually a small amount which is not uncommon, but if it gets larger in size, call your cardiologist.
Forum Editor, Angioplasty.Org, January 14, 2009

• i just had a cardiac cath. done on jan. 06/09 and i have a hard lump below the site and my leg is turning black and blue, it this normal?
Debra, Pennsylvania, USA, January 11, 2009

• Hello. Has anyone had a successful lawsuit against St. Jude's for an AngioSeal STS used in 2005-2006 for migration down the leg? Or any other problem with it moving? If anyone has the instructions for the product from October 2006, I'd appreciate receiving a copy. This is a wonderful page and the editors are to be congratulated.

A friend had complications with an AngioSeal STS being used in October 2006. She was very obese and it is likely that it didn't actual get installed properly. It went down to the calf of her leg and had to be removed surgically. I saw the pathology report and it said that the suture was attached to one piece and a piece of bone to the other. All of this and no coronary artery disease. Anyway, I was looking to find the instruction book for 2006 because the one now on St. Jude's web site is from 2007. I would like to look and see what was contraindicated at that time, such as obesity and if it was of concern that she had blood pressures of 250 over 200. If anyone has one please let me know by emailing me at mat296Q@gmail.com. Also I don't understand why they indicate hypertension could be a problem using an AngioSeal STS Anyone understand why?
Maureen T., Connecticut, USA, January 8, 2009