Angio-Seal, StarClose and Vascular Access and Closure Devices

Current Postings from 2008-09 (92)

• 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

• EM -- Sounds like a hematoma. If it isn't growing in size or swelling, it probably will be reabsorbed over time, but we would recommend calling your interventional cardiologst and reporting it. He/she might want to look at it just to make sure.
Forum Editor, Angioplasty.Org, October 5, 2008

• had a PTCA on 10/2 and they used a Mynx. Layed flat on back first day no swelling or bruising. Next morning noticed a line of purple bruising. By the end of the day there was a 3" x 1.5" line of bruising to the left/medial to the incision site. Some swelling as well, persistent pain and tenderness. Checked with the physician on call and advised that it may be a hematoma. Bruising not getting bigger nor is swelling. Worth a trip to the ER or not?
EM, Massachusetts, USA, October 5, 2008

• Pain and numbness after angiogram. I had an angiogram done September 22nd 2008 and have had pain and numbness down my inner thigh since. I think the starclose has compressed my femoral nerve! The inside of my leg was completely numb for 1 hour after I stood up and dissipated 1 hour after that. 10 days later still occasional sharp pains down inside of leg and incision site. Going to consult with cardiologist. I'm guessing I'll need vascular surgery.
A Doctor, Missouri, USA, October 2, 2008

• I am 49 years old and received angioplasty in Feb 2008. I received the Angio-Seal Closure Device in my femoral artery. The device did not "seal" properly and required pressure to be applied at the site approximately 6 hours after the procedure due to continued bleeding but other than that, I had no problems with the product. I had a second angioplasty 6 days later where the traditional pressure method was used. I was a bit concerned about the device getting in the way or becoming unseated at the time of the second incision and procedure but all turned out fine.
JTP, Kansas, USA, October 1, 2008

• i had a heart cath one week ago.., they inserted an angioseal... i consented because the nurse said it was easier recovery and faster... well i have has persistant pain in my right groin area... it hurts when i walk... i have horrible bruising 1/3 of the way down my thigh... i went back today for a check up and the doctor did and ultrasound and said there were no clots or anything for me go back to work, to take tylenol and get on with my life... i insisted that they pain is there and it gets worse the more i am walking on it... i have even been running a fever... can you have an allergic reaction to the seal? my doctor didn't seam a bit concerned about my pain and now i don't know what to do? am i gonna be in pain during the 90 days while this thing dissolves?
R Duffield, Summersville, West Virginia, USA, October 1, 2008

• Suzan -- as for anti-inflammatories, what about aspirin? Wasn't aspirin prescribed as an antiplatelet drug to take with Plavix? As for drug coverage, check out our Forum Topic on Financial Assistance for Plavix.
Forum Editor, Angioplasty.Org, September 29, 2008

• I am a 56 yr. old who had the perclose device used at my last 2 angioplasties (I have had 4 angioplasties and 14 stents, 10 of which are in my heart)). This last time they had to go in on both sides of the groin. The closure on the right side was fine, but the one on the left produced some pain. It wasn't at the actual penetration site, but about 4 inches away and on the inside of thigh. It was a burning sensation under the surface and almost felt like a muscle was being stretched way beyond its limit. I mentioned it to the cardio doc, but it didn't seem to alarm her. Only felt it when moving a certain way. Anyway it got better in several weeks and disappeared. By the way, my doc has forbidden me from taking motrin/advil/ibuprofen due to increase risk of heart attack. Thanks doc, tylenol doesn't help with inflammation! Also told to stay on Plavix for LIFE....losing drug coverage 9/30/08....looks like I will be petitioning the drug companies soon!
Suzan K., San Jose, California, USA, September 21, 2008

• I had a Star Closure put on my femoral artery during uterine artery embolization on Aug 4 08. The area had a bump (pimple like) on it for the past month and a half. The bump started to go away the last week and now I can see the star closure is actually half way out of my skin. I know it is it because it is metal and star shaped. I don't know what doctor to go see tomorrow. Any suggestions? Back to the Interventional Radiologist? I did not give consent before the procedure and was surprised when they handed me the info card in my hospital room about the closure device.
Ellen, Georgia, USA, September 18, 2008

• I work for a group of cardiologists and am a former x-ray tech. I worked as a tech in the days when you laid flat with a sandbag over the femoral artery puncture site for a minimum of 6 hours. The angioseal seems like a great alternative. My husband has had 3 catheterizations and I had my first one last April...all closed with Angioseals. No problems until my husbands most recent. He developed a staph infection (not MRSA) at the Angioseal that wasn't properly diagnosed until it abscessed thru the skin and he was rushed into surgery. He has been in the hospital for almost a week and I have no idea what the long term prognosis is for his recovery. Those of you who have had great luck, be grateful. There are those who have had life threatening complications.
Karen, Oak Ridge, Tennessee, USA, September 14, 2008

• It seems to me that if one puts the Angioseal in too tight that it could tear the arterial wall and make a larger hole than the original hole. If it is put in too tight the string might break and send the inside flange embolizing distally. Of course these are due to improper placement using too tight an application. The string has to be very strong so it does not break and allow an acute embolization.
Joe Reynolds MD, MHMP, LLC, Bastrop, Louisiana, USA, September 13, 2008

• I underwent a cardiac cath yesterday. I was told during the procedure that the doctor was finished and about to close using a star closure. When he completed the closure, it hurt me greatly. The cath lab staff kept telling me to be still, and I was trying. However, the pain was intense, not at the puncture site, but radiating down my inner thigh to my knee. Now, I am 48 hours out, and my inner thigh feels somewhat numb and my pain is getting worse. I move my leg certain ways and the pain is terrible, again, not at the site, but down the inner thigh. Anyone else experiencing this?
R. Stephens, Birmingham, Alabama, USA, September 12, 2008

• LKG, see our response from September 9.
Forum Editor, Angioplasty.Org, September 12, 2008

• I had an angioseal placed after a cardiac cath. I had no bruising immediately after the cath but then developed bruising encompassing my entire groin and halfway down my thigh with swelling in my inguinal area. Saw my cardiologist and he said that this was normal. Cath was done in June, 2008 and I have been having pain shooting down my thigh since. On occasion it is so painful that I can not move. I am a very stoic person and do not know why this is happening. Had an ultrasound today (OCT.) and my MD said it was normal. He now wants to send me for an MRI if the pain does not resolve within 2 weeks with a regiment of Advil. Any responses will be greatly appreciated. Maybe I should see a neurologist?
LKG, New Jersey, USA, September 9, 2008

• Tom Gillings of Australia writes (May 5, 2008 posting): "I am 50 and had a cardio-ablation 7 days ago. Used a Angio seal. And i am going great, no problems. I think you yanks are a just a lot of screaming wingers. GET OVER IT." Dear Tom: What is a "winger" (screaming, or not?) Please reply to this post as there is a dinner riding on a bet we made after reading yours of May 5 3008 (post).
Val, New York, USA, September 9, 2008

• NZ -- if you read through these comments and those in the related topic, "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty", you'll see that you are not alone. This may be due to the femoral nerve getting nicked or traumatized. This has little to do with the Angio-Seal, but it sometimes happens during the femoral needle "stick". It may go away in time. Some patients in these Forums have found help by seeing a neurologist.
Forum Editor, Angioplasty.Org, September 9, 2008

• I received an Angio Seal back on June 1st, 2008. I had the normal bruising and pain the first few days. However within the first month or so, when I walked long distances, my right groin area would hurt. Recently last month and again this month, approximately a week prior to my menstrual, I have been having a lot of pain in the right groin down to my leg and in my abdomen area and back. Prior to getting the Angio Seal, I never experienced the issues with groin pain/leg pain around menstrual time. Anything that I should be concerned with?
NZ, Colorado, USA, September 7, 2008

• I had a angiogram in July 08. I have an angioseal. It is suppose to dissolve in 3 months. I still feel it. This is my crazy question. A few days ago it was really bothering me. I woke up to go to the bathroom in the middle of the night and my foot was completely numb. Is it possible that the angioseal blocked flow to my foot and caused this? By the way I fell and broke my foot, can't walk on it for 6 wks. It was just a really strange accident and the thought crossed my mind that maybe this could happen. let me know if anyone has had this happen.
Maddy, California, USA, September 4, 2008

• I had the StarClose used on me during a cardiac catheterization in Sept. 06 instead of the collagen plug which had been used two years before. I was not aware of this until after the operation and was informed by the Dr. that this was a "positive" change. Since that time I have experienced pain in the lower right groin and recently there are times of shooting pains that will take my breath away. These are all at the site of the StarClose and when I told the Dr. of this 2 yrs. ago I was told it would decrease with time....it hasn't.
Terrie, New Jersey, USA, September 2, 2008

• Hello, my wife had Uterine Artery Embolization performed 23 days ago. Like many posting here, we were given the StarClose pamphlet in the recovery room. We had no previous knowledge it would be used. The first week went fine and the wound healed normally. Everything seemed to be going in the right direction. The StarClose pamphlet stated that she should experience soreness and tenderness for one week. Now, 23 days later the area is still very tender to the touch and she describes a burning/stinging sensation (4 out of 10 on pain scale). There is also a pea sized lump under the surface of the skin. She HAS NOT experienced any numbness in the foot/leg as some describe, but the discomfort to the puncture sight is constant. Can anyone tell us if this is part of the normal healing process? Should the pain be gone or will it get better? How alarmed should we be at this point? This is very demoralizing for her to finally have relief of one problem only to have possibly caused another. Thank you all very much for your time.
Jayme, San Diego, California, USA, September 1, 2008

• Cora -- the Perclose device is basically a system to suture the artery where the puncture was made -- the manufacturer Abbott refers to it as "suture-mediated" closure. The idea is that is closes the artery more quickly and can reduce bleeding -- the only thing left in the artery is a small monofiliment polypropelene suture. We don't believe that the suture biodegrades.
Forum Editor, Angioplasty.Org, August 9, 2008

• Hi I have been on this site before and I have left a posting in another area of the site. I am wondering re the Perclose device. Does it dissolve or is it permanently placed in the artery? Anyone know information about this device and how it seals the artery?
Cora Doyle, Ireland, August 9, 2008

• I am 39 yrs. old and have a angio seal to the right side of my groin, had no problems at the time it was done. I went back to work 8 days later and that same day a bruise came on my thigh about 3" to the right side of the seal. The bruise is about 2.5" long and 1.5" wide, deep purple in color, with some pain when I walk and some tingling in my toes. Is this something that I should be alarmed about? And what could have possibly happened?
R.M., Georgia, USA, August 6, 2008

• I am a 48 year old female and I had a cath 5 days ago which turned out to show no heart blockage. The AngioSeal was put in and I got up to walk in 1 hour. In 2 hours I should have been going home and the pain in my back got so severe that I could not stand up. A CAT scan showed a bleed with a 3x2 hematoma on my kidney. I was admitted to ICU spent the night, more CAT scans and blood work and I finally went home on Wednesday afternoon. I had to stay at a vacation rental we own as we live in a stilt home and could not do stairs. I am still there today. I am still in pain. The back pain has let up but I have a strange pain in my lower abdomen not unlike cramps which I am done with. None of these complications or this device were discussed with me. I did not have symptoms and was not ill. There was a shadow on a stress test after a one time A-fib event several months ago that was stress related. I would not have had this done if I had known about this risk. The only risk I was informed of was a stroke.
Elizabeth, Spring Hill, Florida, USA, July 26, 2008

• As in any procedure there can be complications. BUT I have had two Angiograms and both used the Angio seal and I am so pleased with them I asked for them the second time around. they are faster to seal and heal, you can get up walking faster and I do not have to worry about an artery blowout. look into what you did after the procedure did you rest the whole day? I know I did not and paid for it with increased pain but a little rest and elevation did the trick. now there are those who might have an adverse reaction to the device as with any procedure/device but to generalize it with pull it off the market NO I want the option of the best closure out there, I an sorry your Doctor did not discuss with you the options but DID YOU ASK him about the procedure and ALL the options I know I did and it is my body and my health so I will ask all questions prior to a procedure I have had an adverse reaction to morphine, so thank God I ask about everything going into my body, when in the hospital with my first cath and wearing a red warning bracelet about morphine a nurse brought two syringes into my room to give to me and I asked "WHAT IS IN THE SYRINGES?" had I not asked wow morphine...it is your health ASK about everything ask the risks even on the table you have the right to know and decide. look up the procedure unless it is an emergency ask what will be used and read up.
Kevin, Arizona, USA, July 19, 2008

• I last posted on to this site 12-12-07, following an unsuccessful surgery to remove the StarClose that was put into my body, without my knowledge or informed consent, on 3-8-07. My pain did decrease substantially, but my leg and buttock are still deformed, due to the device having cut-off blood flow. On 4-10-08 I underwent a second surgery to remove the StarClose, this time with a fluoroscopic table in the OR, and it was removed. I still have numbness from knee to crotch; however, the surgeon says this will dissipate. The "so-called" doctor who put this device in me was incompetent, thank God, and he hadn't gotten near my artery! I feel very lucky in this regard. If you'd like to chat about your experiences, e-mail me.
Iris Newbury, Ph.D., , Cypress, California, USA, Ph.D. (i.newbury@yahoo.com), May 31, 2008

• Had a false positive MIBI with a followup angioplasty and they used the new StarClose vascular closure system which basically worked fine. The problem came when the bill came; I was charged $1596 for the device! That sounds like egregious highway robbery; they come in boxes of 10 units - maybe I paid for all ten!
Bob, California, USA, May 9, 2008

• As a healthcare professional, 53 years old, I had a heart cath due to a positive stress test. I just happened to be going to the cath lab , the same day a rep. was demonstrating the latest and greatest device, called a starclose. My heart cath was negative the starclose was deployed. During the deploying of the device, and although I was still under the influence of versed, I felt 2 very painful "pinches". Since my procedure, 10 months ago, I have had progressively worsening of intermittent, right groin pain. The last episode was 5 days ago, and I almost called 911, it was that intense. I assure you I am not a cry baby or wimp. I do not even know if the severe pain is due to the device. All I know is I never experienced it until I received the star close and other than some allergies to environmentals, I am essentially healthy. I truly believe this object left in my femoral artery is the blame for my discomfort.
M.G., Registered Nurse, West Virginia, USA, May 8, 2008

• I am 50 and had a cardio-ablation 7 days ago. Used a Angio seal. And i am going great, no problems. I think you yanks are a just a lot of screaming wingers. GET OVER IT.
Tom Gillings, Comment maker, Australia, May 5, 2008

• The pain may not have anything to do with the Angio-Seal, but most certainly has to do with something related to te catheterization -- perhaps nerve trauma that occurred during the femoral (groin/leg) artery catheter insertion. Definitely discuss this with the interventional cardiologist. Let us know how you fare.
Forum Editor, Angioplasty.Org, May 4, 2008

• I'm a 43 year old mother. I had the Angio-Seal 7 days ago. I'm having so much pain in my leg and now it seems the pain is moving up. The pain rate is a 7. I can't stand up and walk. The pain gets so bad i can't stand it. The nurse in the hospital said 5 days bed rest and walk after that. That's what i done now i want to cry at times from the pain. What do i do?
Rose, Alabama, USA, April 29, 2008

• Rebecca -- if bleeding from the femoral artery continues after discharge from the hospital, definitely call the interventional cardiologist who did the procedure or other healthcare professional. About 3 patients out of 100 experience complications after a catheter-based procedure that uses the femoral artery. Bleeding is the most common complication. A hematoma or purplish bruise that is growing in size is a signal that some bleeding is occurring under the skin (subcutaneous) -- if the bruise is not growing, then the bleeding has stopped -- the bruise will disappear in time as the body absorbs the blood (this is not unlike getting a "black eye"). All the angio-seal does is stop the bleeding sooner, using a collagen plug which is absorbed into the body over the next few months. But complications can occur with or without these devices. If you suspect anything, call the cardiologist.
Forum Editor, Angioplasty.Org, April 28, 2008

• My mom just got a Angio Seal about three days ago.... There wasn't supposed to be any bleeding or bruising. The hospital gave us a book to keep for 90 days. One thing I'm concerned about as a 15 teen year old is that is the bleeding supposed to continue?? And will the bleeding stop? Nobody informed my mom that the Angio Seal is a device... my mom read these comments and now is worried. She scared that something could happen. I'm worried about my mom and who should she see about this????????????
Rebecca, New York City, USA, April 27, 2008

• I am a 54 year old female that had the Angio-Seal device implanted in me in May 2005 following a angioplasty.The cardiologist did not discuss this with me before the procedure, or ask my permission, it was just done. I was absolutely horrified to read the information saying these devices were NOT to be used on people who were auto immune suppressed. Well, the cardiologist was super busy in the cath-lab that day so he had his P.A. do the pre-op physical. They simply were too busy, they over looked my terrible psoriasis on my right leg. The P.A. said my skin was clear. WRONG. I have had terrible right leg pain ever since. The worse thing is I have chronic yeast infections every three to six months now, which I have to take medications for. This likely will go on for the rest of my life.The cardiologist was supposed to put a stent in for my clogged artery, but decided not to. Thank God for that. I for one have had nothing but problems ever since they used this device (Angio-Seal) to close my femoral artery. I personally think they should be pulled off the market, before they ruin any more lives. They used these to do more procedures and make more money. Really they don't have the time to just stand there and hold pressure,(that's considered the old way.) The bottom line is they use these devices because they can make more MONEY by doing more procedures. I have filled out the form on the FDA website and I recommend anyone else having problems do the same. They have to know by now. Something should be done. My cardiologist is so busy doing these procedures he does not have time for follow up visits. I have been rescheduled eight different times in four months. He knows he messed up now he does not want to hear my complaints. I am going to get a lawyer and do something about this if possible.
Kathy S., Illinois, USA, April 26, 2008

• An angio seal was used on me after a negative result heart cath. I developed swelling that first night home and it became worse the next day. I went to the E.R. and the bruising and edema were even more worse. At this point..the doctor had a ultrasound/doppler of the groin. They told me it was a large hematoma and to keep an eye on it. I was afraid that something was going to break loose and go to my heart. I missed two full weeks of work,and still have to apply a heating pad to the area at bedtime. The stiffness kills me and my entire leg wants to fall asleep at time, like my circulation is being disrupted. It's been 2 1/2 months now with these ongoing symptoms .... I wish they would have never placed it in my body. I had no clue that they were even going to use the stupid thing. It still feels too big for my small leg artery, but I can't do anything about it now...best wishes to all...
T.L.B., Ohio, USA, April 22, 2008

• To R.F. in Maine posting USA, March 2, 2008 concerning your angioseal. I have had very similar reactions with my Nitinol Star Closure Device. It turns out that I am allergic to the materials found in the device. What you are experiencing may be an allergic reaction. My activity level seems to be directly related to the severity of the reaction. My daily ritual of meds are 1 Allegra a.m. 1 Benadryl afternoon 1 Allegra mid-day 1 Benadryl mid evening and then 2 hydroxixine at bedtime. Try taking Benadryl and ice the area. If you get any relief, however small, yours maybe allergy related too. I will be having surgery to have this device removed within the next 2 weeks. I will post after this surgery.
E.S., Dallas, Texas, USA, April 14, 2008

• The last two postings show the range -- they are both about the StarClose device, one describes a serious complication and the other discusses how much better the StarClose was than the first conventional closure. Complications are relatively small in number, but it is not small when the complication happens to you.

What the medical profession does is look at the big numbers. Does one closure device have a significantly larger complication rate than others? How does it compare to the complications seen with conventional manual pressure? A few years ago, an analysis of the NCDR Registry did just that and found that the VasoSeal device was associated with a greater complication rate -- this data analysis caused the device to be withdrawn from the market. We urge all patients to post their experiences here (for all to read) but also to file a formal report with the FDA, if they experienced a complication. Hospitals are supposed to file these reports, but they don't always.
Forum Editor, Angioplasty.Org, April 12, 2008

• I am a 26 year old mother of 2. I recently had an angiogram (2 weeks ago) and when the procedure was done I had the "normal" applied pressure and was closed up and sent to recovery...waited the 4 hours and was sent home. The pain for the next two weeks was horrendous. At the end of my two weeks I was scheduled for the Gamma Knife for the second time in 7 years. Part of the procedure is a angiogram (again) I believe because of needing to be able to go back downstairs for immediate continuation of the procedure I was given the *starclose* as opposed to waiting for the conventional closure waiting time. I had the Gamma Knife and later was given the pamphlet about the starclose and barely remember being told I was receiving it only hearing what sounded somewhat like a staple gun clicking about four times. After reading all of these entries about negative responses I have to say I so far feel that the recovery is MUCH better than the first angio where I had regular closure and the waiting period when I felt sooo much pain following...I couldn't walk and my legs were numb for t weeks...with the *starclose* I feel slight discomfort and a lil rockish feeling at the sight but not much more. I did just have four screws in my head and the pain may be more concentrated there so I may not be feeling my leg as much but it is definitely not as bad as it could be. I am also usually not able to take the time to recover as I should be the mother of a five year old and a five month old. I feel bad that there were soo many bad experiences with these devices but I only had it done on Fri April 4th, 2008 and it is now Tues...sooo far soo good! So it is not all bad. I think everyone heals differently and everyone's body handles and accepts or denies things differently as well. I am hoping that things remain in good standing for me with this but good luck to the rest as well.
J. Johnson, Pawtucket, Rhode Island, USA, April 8, 2008

• I had a cardiac catheterization on Nov. 19, 2007. I had not been informed before, but a Starclose device was used to plug the femoral artery. After procedure I started having pain in my right leg after walking 50-60 feet . Further tests confirmed that Starclose is blocking my artery . I had a very serious operation to remove Starclose and repair my artery. After 2 months I still have pain . I have a bare-bone insurance, and this unexpected repair operation cost me a small fortune. Is it the fault of doctor performing catheterization or is it a faulty Starclose device ?
K. D., New Jersey , USA, April 8, 2008

• To the two Lizes -- Liz from UK -- the bruising is called a hematoma and comes from bleeding under the skin -- it usually disappears, but if it hasn't or is growing, and if the pain you're having doesn't resolve, definitely discuss this with your interventional cardiologist.

Liz from Florida -- we're sorry to hear of your problems. It's also possible that the damage to the femoral artery was caused by the cath itself (needle puncture, etc.) and not the closure device, but suffice it to say, it's one reason we have been trying to educate patients and doctors on the use of non-invasive CT angiography for diagnosis, where appropriate, especially to rule out coronary disease (it is excellent for that) and also to promote knowledge about the radial approach, where the wrist artery is used instead of the femoral. Not appropriate in every case, but has been shown in study after study to singificantly reduce access site complications.
Forum Editor, Angioplasty.Org, March 31, 2008

• My heart cath was three years ago, an Angio-seal was used. The femoral artery was damaged which has required two by-pass surgeries. I also had a staph infection that took months of home IV care to clear. The numbness and pain are still very problematic. I gave up on pain management two years ago and simply live with the pain and limitations imposed on my life by a medical product that should have been recalled years ago. A compression stocking helps a bit on the really bad days. My cath was clear, no problems (my teenagers were stressing me out!). I am 44 years old and now have to wonder how long my by-pass will be functional. I am terrified of going through another femoral by-pass, but have been told that 10 years is about average for by-pass expectancies. I wish I had never used the Angio-seal and I strongly suggest that compression is used over ANY closure device. This is very important in woman with small veins, stature and is clearly indicated on the instructions of all closure devices. I guess the doctors prefer quick ambulation and the extra profit over the well-being of their patients.
Liz W., Florida,USA, March 27, 2008

• I had an angiogram followed by the insertion of an angioseal 10 days ago. I was told there would be a small amount of bruising and a little lump at the insertion site. Half of my right thigh is black and blue and there is a pain not unlike a torn ligament which runs from my groin nearly down to my knee. I also have a dull ache across my lower abdomen.The lump itself is hard and painful and yesterday my lower back went into spasm on that side. I am having great difficulty sleeping as the pain wakes me every time I move. Any idea how long this is likely to carry on?
Liz, United Kingdom, March 26, 2008

• I had a a angiogram a few days ago. Afterwards I found out they used an Angioseal & I am not happy about it. If I had been given a choice between nothing being left in my vein & the angioseal I would have chosen nothing. Now I am constantly worried that something is going to go wrong or a piece is going to separate and go drifting through my blood stream. The only reason, as far as I can tell, that they used the angioseal is so I could be discharged about 3 hours faster. Of course now I have to worry for 90 days that something will go wrong. I would have gladly stayed overnight so that I would not have to be burdened for 90 days worried about this thing. To say that I am pissed is an understatement.
S.D., Kentucky, USA, March 21, 2008

• All of you who are having issues related to an internal closure device, please accept my apology that you were treated with one with no informed consent. It is an unexplainable phenomenon that eludes me (a cardiac nurse) why patients are not informed of the risks associated with the devices. There is an option to closure devices called Syvek (www.syvek.com) Very safe and nothing is left behind. Ask your physician about this topical device as an option. If he/she has not heard of it and it is not an option, demand manual compression with gauze. It takes longer, but does not have the risks as internal closure devices do. I wish the best to those of you with complications for a speedy recovery.
K.N., nurse, Ohio, USA, March 14, 2008

• I had a heart cath in 2002, they used an angioseal. The day after I had sharp shooting pains into my abdomen. I went to the ER and had a doppler which they said was fine. I almost passed out from the pain when they were up higher than the site. I was unable to straighten up to walk since the pain was so severe. I went back to the ER after a few days and they finally did a CT scan. They found a retroperitoneal bleed. I was hospitalized for two days. My problem now is that I am having increasing right groin pain radiating into my thigh after I have been walking for awhile. Sometimes it goes clear down to my knee. I am wondering if this is from scar tissue at this late date and who I should see about this?
Cherilyn S., Illinois, USA, March 7, 2008

• Carol Ann -- as you can see, your story is unfortunately not unlike many others posted in this topic and the related topic in the right column, "Complications from Femoral Site". So many patients write in that they've been told there's nothing wrong -- except they are experiencing significant pain, right where the catheterization was done.

First of all, this may or may not have anything to do with the AngioSeal, which is a just a closure device for the femoral artery. It may have to do with some type of complication that occurred around the femoral artery access site -- for example, sometimes the femoral nerve (which lies parallel and close to the femoral artery) gets traumatized or pinched during the needle stick, or the closing. Sometimes this pain does go away. Some patients have had success seeing either a vascular surgeon or even a neurologist. One reason that physicians say nothing is wrong is because they have no way of seeing or measuring something (it's just your word...). But a neurologist actually can run a test to see if there's nerve involvement causing the pain. Good luck and let us know how things turn out.
Name, State, USA, March 2, 2007

• In November of 07 my dad had an angio-seal. He has had terrible pain in his right groin area ever since and has gone back once to the doctors whom did the procedure and was told there was nothing wrong. He also saw his PCP and was told there was nothing wrong. Just about two weeks ago one of his doctors passed away and now we are really in a bad place. I am very concerned because he has such severe pain he can hardly walk at times and sleeps less and less. On top of that he worries a lot about it and that doesn't help the situation at all. Please help me!! I am willing to share any and all information I find if you all will please do the same. I need to find a doctor who will help.
Carol Ann, Kansas, USA, March 2, 2008

• R.F. -- did you begin any new medications at the same time? Some drugs, such as Plavix, can have this effect -- however, DO NOT stop taking any drug without consulting your cardiologist -- it can be harmful, especially if you've had a stent placed.
Forum Editor, Angioplasty.Org, March 2, 2008

• I'm eight days out from receiving the angio-seal. I just started getting rash on my right leg (same side) abdomen and left leg. Anyone have this problem and should I be concerned?
R.F., Maine, USA, March 2, 2008

• To the person who sent in two extensive postings to this topic, with the initials J. E. T., your comments are most interesting and you obviously spent a significant amount of time writing them, but your email address is invalid -- there is no such domain -- and we have a strict policy of not posting any comments unless they have been sent from a valid email address. Please contact us and we will post the comments.
Forum Editor, Angioplasty.Org, February 28, 2008

• Just to let you all know..there is a new closure device called "Boomerang Catalyst" out there. It allows you to walk sooner, in two hours, all while leaving nothing behind in your vessel. Check it out on-line. There is no risk with this device as there are with devices that stay in your vessel. If you are looking for a more natural method to closure, this is it!
R.K., Ohio, USA, February 18, 2008

• On 01/21/08, I underwent a right femoral angiogram and a Angio-seal device was used to plug the artery. As of 02/04/08, I have had no bleeding and very little soreness. My job requires lifting up to 100 lbs. from ground level. Any thoughts as to when/how long I should wait before returning to work?
Joe E., Arizona, USA, February 4, 2008

• I had a cardiac cath done on 2.1.2008 and had an angioseal put in without my knowledge. I've had a cerebral angiography done a yr and a half ago and I was not in pain like I am right now. Why is that?
Grace, New Jersey, USA, February 2, 2008

• The FDA has recently approved AccessClosure's Mynx Vascular Closure System. Are there any thoughts about this replacing Starclose and Angio-Seal? Has there been any complications reported from the Mynx device? Thanks in advance.
Tom., New York, USA, January 27, 2008

• Unless I am wrong patients should be advised that using any closure device should not be billed as it is part of the procedural package. The choice to use any one of the devices is certainly debatable; one over the other or none at all. I think I would prefer a pretty nurse apply pressure to my groin than rely on a controversial device. My point is closure is closure and is part of the cath or surgery or injury.
P., Georgia, USA, January 11, 2008

• Byron -- this forum topic is only about problems (or not) with vascular closure devices, something you should discuss with your cardiologist. As to your specific situation, it sounds like you have what is known as a "total closure". This is a topic of great discussion among interventional cardiologists and surgeons. There are questions and debates over whether it is beneficial to open a totally blocked artery, especially when it is well-collateralized. An important piece of information is whether or not the part of the heart muscle supplied by this artery is being under-perfused, that is, getting less blood flow/oxygen, than it requires. If so, increasing that may be of significant benefit. It's a complicated situation, and we would recommend discussing this more with your cardiologist. By the way, normally a cardiologist would not be doing the bypass surgery -- that would be performed by a cardiothoracic surgeon.
Forum Editor, Angioplasty.Org, January 11, 2008

• After reading this forum, I am very reluctant to go ahead and get angioplasty. There are so many negative comments about it, I just got diagnosed with at 100% blockage in the right artery and the 64ct showed that collaterals are giving me the chance to live. The cardiologist says he will try the stent placement, if not possible through the angioplasty he will then do the minimal invasive bypass. I am very concern now if I should discuss with him all these bad experiences described here and go straight to get a bypass.
Byron, San Fernando, California, USA, January 11, 2008

• Scott -- you've hit on one of the reasons hospitals use vascular closure devices (there are a number on the market). It's called "early ambulation" -- the patient can walk sooner and thus, in an uncomplicated case such as a diagnostic cath, there is no overnight stay involved. The sandbag method requires extra nursing time, discomfort, etc. as well. The swelling should go away, but we urge you to talk to your cardiologist (the one who did the cath) if this does not resolve. Too often, the doctors doing the procedures never get the feedback from the patient.
Forum Editor, Angioplasty.Org, January 11, 2008

• I had the Cardio Cath procedure on the 20th of Dec and they found no blockage and all went well with the exception that the Dr was late (Instead of the procedure beginning at 10AM -- I went in around 6pm) and I wasn't given the options for closure devices or traditional manual pressure and I had the Star Closure. This feels like a little rock under the skin, hurts when running if I take long strides, and areas around it are extremely sensitive. I asked about having this removed and was told I'd have to see a Vascular Surgeon and it was extremely risky. What are my options and is there a way to explain why a doctor would use this as opposed to the traditional sandbag on the groin for 4-6 hours? My impression was the lateness of the doctor lead to the need to use an expedient closure to prevent my required long term stay (Potentially overnight given the hour of the eve when the procedure was completed 7pm).
Scott , Tampa, Florida, USA, January 11, 2008

• Stephen -- thanks for writing in. We host these Forum Topics, but we try to emphasize that all the various complications described here and in other threads are a small minority of cases. This is not in any way to minimize some of the pain and suffering caused by these complications, but it's a reminder that they only occur about 3-4% of the time. The great majority of patients have an experience more like yours. That being said, raising the issue and the type of complications is an important task -- and patients have very few "forums" to communicate these stories.
Forum Editor, Angioplasty.Org, January 11, 2008

• I am a fit 65 year old just out of hospital after my seventh angiogram -- four of these were for stents. I have always been fine post ops, and the angio-seal has always been fine with just a bit of soreness and a small lump for a few weeks slowly disappearing.
Stephen M Bishop, U K, January 10, 2008

• Terry -- the Angio-Seal is a temporary seal -- holding the puncture site in the artery together, not unlike a band-aid, to prevent bleeding. When it has done its job, it (usually) is absorbed and no further seal is necessary because the artery has healed.
Forum Editor, Angioplasty.Org, January 8, 2008

• I had an Angio-Seal vascular closure device inserted in my femoral artery, about a month ago. I was given a leaflet about the device, which says that "The device is absorbed within 90 days of placement". If this is the case, what happens after 90 days - do they have to insert another one - or a more permanent one?
Terry Slattery, Spain, January 6, 2008