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Angio-Seal, StarClose and Vascular Access and Closure Devices

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Post questions and comments about vascular closure devices, like Angio-Seal, StarClose, Mynx, Perclose, Syvek, etc.

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Current Postings (118)

• Ken in Massachusetts - This topic is specifically about complications from a vascular closure device. You should also look at the related topic "Complications from Femoral (Leg) Catheterization, Angiogram or Angioplasty." By all means call the cardiologist who did the cath and let him/her know about this. Most of the time any complications like these are dealth with by the Emergency Department or a family physician and the cardiologist never hears about them - one of the reasons that we (and a number of cardiologists we've spoken with) believe that access site complications from the femoral approach are under-reported.
Angioplasty.Org Staff, Angioplasty.Org, July 16, 2013

• I had hearth cath done on 7/7/13 and have experienced severe pain bi-lateral pain from L5 down to my knees and outer calf. The pain does not let me sleep even with pain medicine. It sounds like femoral nerve damage. Any solutions? I thought it was due to increase in Zocor so general family backed off script with no success but reading this site it sounds like nerve damage.
Ken, Massachusetts, USA, July 14, 2013

• I have had Angiogram in 2009, to this day 7/1/2013. StarClose has given me pain since. I reported it but no answers. Had x-rays now, I have burning rectum, and groin burn. They say show the card, well I did, the person whom I showed it to, did not even know about it, and said it will be ok. No it wasn't, so now I have to live the burning constantly. Why can't any one face up to the fact that StarClose is indeed dangerous for some people. We have to live with the results....There needs to be some way they can reverse the pain..
Doris, Upland, California, USA, July 1, 2013

• Shanrob in North Carolina - The StarClose does not dissolve. The clip, made of nickel-titanium alloy (called nitinol), is permanent. Why it is not showing up in airport scans may have more to do with the accuracy of those scans than anything else. The complete "Instructions for Use" for the StarClose SE can be found here.
Angioplasty.Org Staff, Angioplasty.Org, June 9, 2013

• Does the StarClose SE device dissolve? It is nit-titanium alloy. and I was told it dissolves after the surgery. I received a card to carry with me in airports and places where metal might show up. I had an X-ray done also and it is not showing up in the location it was placed and I need to know if this mean it has moved or if it in fact does dissolve as I have been told.
Shanrob, Charlotte, North Carolina, USA, June 7, 2013

• Stormy in Texas -- Thanks so much for posting a positive experience. We've often written that minor complications from these procedures are around 6% or less; major complications far lower. Of course, reading this Forum Topic, you'd think that complications were the norm. That's mainly because patients usually only post comments if they've had a problem. So we're seeing a condensed, self-selected group of negative outcomes. Stormy, you haven't been one of the lucky ones, because 95% of the time, patients have the same kind of outcome you have had. Of course, if you do wind up having a complication, the low rates are pretty meaningless because, for you, the complication rate is 100%! We encourage more patients who have not had problems to post comments.
Angioplasty.Org Staff, Angioplasty.Org, May 20, 2013

• I had a STARCLOSE after recent heart cath and a previous one after having stents in leg. I have had no problems what so ever either time. I do EXACTLY what the doctor orders in reference to recovery, and probably go to extremes. I have complete bed rest for 24to 36 hrs. When I did get up I was told I could lift no more than what a gallon of milk weighs for at least 7 days. I used the down time to catch up on tons of movies and reading books. I do however do extensive research on the Doctor(s) that I choose to perform any type of procedures on me. Guess I've just been one of those lucky ones, so far, and feel for those that remain in so much pain.
Stormy, Houston, Texas, USA, May 18, 2013

• Johnno in Cleveland -- It's odd that you would have gone for quite some time without this constant pain, and then two years later, it has returned. It's possible that the femoral nerve has somehow become involved. Hard to say. We'd suggest reporting this to the interventional cardiologist who did the stent procedures, but also it might be useful to consult a neurologist to see if this is nerve pain. The femoral nerve lies right along side of the femoral artery. Perhaps something is now impinging on it. Let the Forum know what you find out and good luck.
Angioplasty.Org Staff, Angioplasty.Org, May 5, 2013

• I went in for two coronary stents about two years ago. First attempt, they tried unblocking/pushing through one of the arteries, apparently dislodged something and put me out. Kept me in and performed the stents the next day or two... I forget but I was in the hospital nearly a week. They used a star closure on my right side. I have had off and on pain since then - mostly off but about a year ago I had consistent pain for about two months. The last three weeks have been agony. I drive a dodge nitro... Essentially a jeep liberty which sits a little higher than normal and I actually have to grab my pant leg and lift my leg up to get in. Pain is like a constant burning in the groin area where the closure is. When moving or positioning I get pain varying from sharp jabs to dull throbs down right front to knee, sometimes but rare pain shooting down near ankle or wrapping around/through right hip. I had a lower back injury about 25 years ago at work and I've experienced sciatic nerve pain on left side over the years. Although this seems similar in some ways it is also somewhat different. I am 49/male. Could this be complications from this closure? If so - what to do? Thx.
Johnno, Cleveland, Ohio, USA, May 5, 2013

• I had the StarClose in my right groin in 2011. I am allergic to metal, and I have had so many problems. I could not even cross my leg, and when I would ride for a while, and try to get out of the car, I couldn't walk. Dr. H'Doubler of Jefferson Surgical Clinic in Roanoke, Virginia, removed it on the April 25, 2013. He is a wonderful Doctor, and I would recommend him to anyone that wants theirs removed.
Patsy, Patrick Springs, Virginia, USA, April 30, 2013

• I had a heart cath on Apr 4, 2011 in St Rose Hospital in Las Vegas. A Mynx Device Closure was used and it failed to deploy. Cardiologists and the staff nurses were attending me for almost an hour due to profuse bleeding. I had 10-15 heart catheterization w/ Angio-Seal used and this was the first time Mynx Device was used and the pain was so terrible within the first 24 hrs. No sleep all night. My groin had a big hematoma and the pain lasted for almost a month. What a bad experience w/ this device!!!!!
Jay-ar, Las Vegas, Nevada, USA, April 17, 2013

• I had procedure done in January 9th 2012 at IMC Murray Utah and the Dr. [used] StarClose Device to close. I have a pain in my right groin. I go back my Dr. who did the procedure and put stent. He order ultrasound CT Scan and every time they find nothing wrong. But I never have any day without pain some days are worse then the other. So far seen four different Dr. But today 03/05/2013 he told me that nerve get damage due this StarClose device and recommend to see Neurosurgeon and hoping he might able to find solution for this pain if this happen then I will post again because I am going to see the Dr. on 03/12/2013
TC Verma, West Jordan, Utah, USA, March 5, 2013

• I unknowingly had a starclosure [StarClose] in '07 after a negative heart cath. Was told when I was discharging from the hospital to call 911 if my staple ever gave way because I would bleed to death. Six months later I began having worsening allergic reactions. I'm allergic to metal and knew this before surgery but was not consulted. In 2012 pain started in groin with dripping feeling and sudden attacks of going into shock. PCP obtained records of procedure and I just now found out I have this star closure [StarClose]. Terrified I will have this the rest of my life. I have gained a large amount of weight since symptoms began. Looks hopeless.
Rose J, Knoxville, Tennessee, USA, February 10, 2013

• I received the StarClose without my consent which makes me angry after asking for explanation of the procedure and possible outcomes that closure was never mentioned. That was in 2008 I still have pain I'm a little fearful I've had an ultrasound in 2009 which showed nothing, inquired about the possibility of it moving out of place and was told that would not happen still concerned though.
Yolanda, Saginaw, Michigan, USA, January 28, 2013

• I had a heart attack in 2006 StarClose was inserted post-stent placement in coronary artery my right groin has the StarClose and Ever since I have pain in my groin, down my right leg,knee, and foot sometimes achy, stabbing, and chronic, and I feel it in my spine right side but nobody wants to hear it. What do I do? My PCP is condescending and says well" you know you had a heart attack and that's traumatic" see a Psych. It has nothing to do with psych it is real pain why won't Drs address it? What do I Do? HELP the pain is terrible sometimes and when I move about it is uncomfortable.
Roseann, North Hampton, New Hampshire, USA, January 18, 2013

• Tina in Ohio -- If you read through these posts and back through the archives, you'll see more patients with similar complaints. In fact, there are over 700 posts in this topic. Also check out our related topic, "Complications from Femoral (Leg) Catheterization, Angiogram or Angioplasty."
Angioplasty.Org Staff, Angioplasty.Org, January 13, 2013

• I am almost 45 now. In 2010 I had the star closure [StarClose] put in my right groin after heart cath. I didn't have anything wrong with my heart or arteries was having anxiety attacks but to no avail they sent me for this heart cath. Every since I have had pain in the area down my right leg into my foot. Sometimes it is dull and achy and sometimes it is a stabbing pain. It has been getting worse here lately. I have said something to the doctors and they tell me that there can't be a problem with the star closure. Then I wish someone would explain why I have these problems now. I can't even get a doctor to even look at the site let alone take an MRI. what do I do?
Tina, Ohio, USA, January 12, 2013

• My husband had a stroke 6 months ago, he had a stent put into his head with the Angio-Seal in his groin, 3 days later I get a phone call telling me he needs emergency surgery to remove a seal that dislodged into his knee (didn't even know he had a seal) was told surgery would take 1 hr. 4 hours later I was told the seal was stuck to a vein and had to be taken out piece by piece and had to have a vein by-pass because the vein no longer looked good! Now stuck with a cane and daily pain. Asked why this happened and was told it sometimes happens! Why was this seal not checked daily if this can occur? Why 3 days later? I call it abuse, lawyers don't want to help because of the stroke. And I get stuck with the medical bill because no one bothered to check a seal! Husband is recovering from his stroke well only the speech is affected still but he cannot walk without a cane, cannot sit or stand long. He can only walk for about 5 minutes until he needs to sit because his leg with the by-pass hurts too much. He's 55 and was very active so its killing him not to be able to do the things he loves! Please if anyone know how I can help make Dr's be accountable for this Let me know. Thanks
Polly, Marlton, New Jersey, USA, December 29, 2012

• I too had STARCLOSE after a negative cardiac cath several years ago. 7 or 8 years ago don't recall exactly. I still continue to have spasms in my right groin especially being awakened at night with excruciating pain that actually takes my breath away. This lasts less than a minute, but during this time, I feel as though I might die. this has caused an increased fear & anxiety as no Dr. really has an answer & looks at me like I am just a middle-aged hysterical person. The pain is real and although the worst occurs at rest, I have a continual tender area at the insertion sight and now suffer from numbness and tingling that I attribute to this procedure. As with several others who have posted, I was only momentarily spoken to as I was being wheeled to the cath lab about this new invention that was just marvelous & would allow me to be up walking 2 hours post-cath instead of 6. Why was no one aware of the seriousness of the pain and spasms post StarClose??? What options do those who have one placed have? Can it be removed? Can anything stop the pain & spasms?
It's me again (I posted previously), Morgantown, West Virginia, USA, December 12, 2012

• I had the Mynx closure device placed on 11/12/12, since then I have had tremendous pain in my right groin, extending down my thigh and into my knee. I can't even lift my leg up to get dressed! I went to the ER 11 days later, nothing was found on the Doppler except some "fat stranding" and an enlarged lymph node. I was given pain meds, saw my doc, given Ibuprofen and pain meds (insurance won't cover Celebrex),and guess what--I've still got the pain! Any suggestions/help out there?
Janab, El Paso, Texas, USA, , December 3, 2012

• Allergic Reaction to Mynx ( which is made of polyethylene glycol) could result in what I am going through now. Allergic reaction to PEG 3350 is rare, but it is a possible side effect of taking the drug. Consult a medical professional immediately if rash, hives, itching or swelling of the face, tongue and lips occur. These are signs of a serious allergic reaction, which can cause problems with breathing or maintaining normal heart function. Mild allergic reactions can be treated with antihistamines that relieve itching, rashes and hives. If anaphylaxis occurs as a result of the allergy, an epinephrine injection may be given. Corticosteroids and bronchodilators can also be used to treat some of the signs of allergic reaction to PEG 3350. Read more: http://www.livestrong.com/article/29869-polyethylene-glycol-side-effects/#ixzz2D6nKKgo2
Wayigan, Tullahoma, Tennessee, USA, November 23, 2012

• Angio-Seal put in after cerebral-angiogram. Four Days later started experiencing inner thigh pain down into knee and inner calf. I spoke to the doctor who did the procedure and he said this was normal and it would go away over time as the collagen seal eventually dissolves, and that if the pain increased to call him and he would write an Rx for a pain killer. I like others, was NOT made aware that the device was going to be used, NOR was I even told about it afterward. I found out it was in there when I read a copy of the procedure report - not informed, educated on after care for it, no brochure or ID card given to me. I had to go back to the hospital and ask for it! I return for follow-up in 2 weeks, if pain persists I'm asking for an ultrasound.
Patient in Texas, Houston, Texas, USA, November 18, 2012

• This will be my fourth and final post regarding the StarClose device. My first post was in 2008 when I had severe leg pain following an angiogram using the StarClose device.
Order of subsequent procedures and outcome:
Sonogram - 2 days after procedure was negative for aneurysm
MRI - I ordered it a month or so later and it showed the device was in close proximity to the femoral nerve.
Vascular surgeon - 2009 saw surgeon, he stated removing it and resecting the femoral artery could be "going from the frying pain into the fire".
I have seen the cardiologist who did the angiogram and he told me that this complication isn't possible and dismissed me. Like you all said: UNDER REPORTED As a result, I will have intermittent yet severe pain in my right leg for the rest of my life and will not be able to do many activities. (Anything involving right hip abduction, flexion, or external rotation). BTW: I took your advice and reported this event to Medwatch. It is the only thing I can do about it.
dnewton1111, Missouri, October 22, 2012

• I had a stent put in On August 15th 2012 with use of Angio-Seal. Since the day I left the hospital my leg cramps when I walk, and my leg tires out quickly. I called Dr and should have spoke to Dr but spoke to nurse who said it was normal (about a week later). I continued to not be able to walk more than say 50 steps without cramp and pain. Forget about hills, ramps or stairs. I just got a CAT scan of the site and after going around the barn they say I have almost a complete blockage at the site. The blood has managed to form small canals around the occlusion(?), but I will now need a another stent in what WAS a perfectly good artery. I have moved to a new state and am in my last semester for my BA degree (no I am not young). I have no insurance here and cannot go back to my home state or will lose an huge investment of time and money. I just want the repair paid for!
Minnie, Utah, USA, October 4, 2012

• Great recovery with Angio-Seal! I'm so sorry so many of you have had difficulties with this device. After a heart catheterization 9 days ago, an Angio-Seal was placed in my femoral artery and I have absolutely nothing negative to report about it. I'm sure that the surgeon was exceptionally good. I had some restrictions regarding hip and leg motion for a week which made it a challenge to find a good sleeping position (I sleep in a fetal position). My husband insisted that I do nothing but rest for the week so I would heal quickly. It may have been overkill but it worked! I feel great!
Sandra, Mt. Airy, Maryland, USA, September 26, 2012

• Hello. I had a heart Cath last Mon. all went well and Doc used MYNX VASCULAR CLOSURE device, which the staff stated that this was the best on the market fast, fast recovery. Man I have been in so much pain what a drag, I have this hard lump about the size of a half dollar, will be heading back to doctor tomorrow, fast recovery right!!
ecr9343, New Jersey, USA, September 13, 2012

• Had heart attack 12/20/2011. Flown from Pierre, SD to S.Falls, SD on 12/21/2011. Had angiogram, using Angio-Seal Vascular Closure Device (without my knowledge). Discharged 12/23/11. No problems then. Was riding to Omaha, NE on 12/24 for Christmas w/children when I got sick. Fever & thought it was flu. Admitted to Hospital in Omaha on 12/25. Had severe staph infection of blood stream and spine. Was hospitalized 2 months. Returned to Pierre and was under Dr.'s care until 7/30/2012. Terrible back/leg spasms/incredible pain. Found more staph on June 1 in Pierre + abscess. Had 6 weeks of daily Daptomycin injections. Am finally feeling better. Back still bothers. I feel the closure did not properly close. Looking to see if others have had this problem. Angiogram site was swollen hugely for about 2 months. I blame it all on improper closure due to this new Angio-Seal. Are there any class action lawsuits pending against this product?
Janice Russell, Pierre, South Dakota, USA, September 10, 2012

• i received a StarClose renal closure system in 09 without my consent, as the Dr was running late and his schedule got behind, and subsequently, did not receive the "sandbagging"/manual method, even tho i would've stayed the hours it took for the manual to be successful enough to leave hosp after angiogram - this outraged me, [after i was given a brochure as i left as my way of discovering a had a device in such a dangerous area - i have suffered extremely acute and intense shooting pains occasionally in my groin area and testes on the side of the StarClose since that event - i wait in dread of the day it's compromised by an MRI or other event -
Dr Steven Whipple's Guinea pig, Seattle, Washington, USA, August 19, 2012

• had heart cath July 2011 and was closed with Mynx closure and after that i started having severe right foot pain. was carried back to room and pedal pulses were barely there. spent night in hosp for observation and pain worsened,us done showed clots in arteries, taken back to heart cath lab retrieved 4 clots but couldn't get them all. was place in ICU with clot busting agent going directly into femoral artery and for 3 days in a row to heart cath lab and arteries are still clogged, bleed severely hgb. of 7 . had a procedure in Jan. and march 2012 trying to open arteries, unable to do so. have to take pletal, Plavix, aspirin 325 daily and wear compressions hose lifetime. My leg still is not as it was before this happened. was told by doctor that the sponge came off Mynx closure and caused the obstruction. what can you do ??
nurse 38, Georgia, USA, August 2, 2012

• my husband had the StarClose vascular closure device put on his right femoral artery after a heart cath in 2007 after a lot of medical problems we went to a vascular surgeon and we found out it fell off it was behind his lymph node so they had to do surgery and remove his lymph node to remove the device that fell off and for those who don't know there was 2 recalls on this device one in 2007 and one in 2009 and they did not have to notify the patients who already had it implanted it was a voluntary recall go to your FDA web site www.fda.gov look at the card they gave you to carry about the device your numbers are on it.
it's just not happening, Franklin, North Carolina, USA, June 8, 2012

• My husband had a cardiac cath 8 days ago with and Angio-Seal. This morning he had excruciating pain in the groin area. He said it felt like a burning sensation and then is radiated. When he doesn't have the acute pain, it is an aching pain. It was so bad we went to the ER. They did ultrasound, CT, and blood work. They found nothing significant, even though he had two more episodes while in the ER. He was sent home with a script for pain. The episodes occur when walking, sitting up, or with movement. This evening, when he laid down, he had another acute episode of groin pain along with acute pain in his stomach. He does not want to return to ER because they did not find anything. He is 57. The cath was for pre-op to mitral valve surgery. They said they the cath was fine. I am very concerned about what is causing this pain. It sounds very similar to what I am reading from others. I am at a loss as to how to help him.
Marie, Phoenix, Arizona, USA, May 27, 2012

• I had a heart catheterization done a few years ago at a heart center in Norther Virginia. My heart was fine but since then, I'm having increasing pain in my groin area, down my leg, the back of my right knee down to my foot, and in my right buttock. I wake up several times in the night with burning pain in my foot. The pain is affecting my job and driving. I've let this go on too long not knowing the cause. I'm so glad I found this site. Where do I start to have this problem corrected? GP, Heart doctor who ordered the unnecessary test, the heart center who preformed the cath and inserted the angio seal? I'm an otherwise healthy 51 year old female and I can't even walk on the beach in the sand. HELP!
Becky, Washington, D.C. Metro, May 26, 2012

• Sorry about NOT explaining completely! He had his 3rd Cath, he already has 2 Stints [stents] that were put in back in 2009 & he did fine! This time they used the: Mynx Device..They did it in his RIGHT leg but its his LEFT LEG is swelling/severe pain in thigh area. I called the Dr & Hospital all they did was "DISMISS ME" telling me it is NOTHING they/he did! Plus that they NEVER touched his other leg! Now he has to go in the am, to see "IF" it threw a clot! Or "IF" there is some type of NERVE DAMAGE! He is NOT able to lift his leg but with his hands/no stairs/no long sits/no long standing/EXTREME PAIN! "SHOOTING" down his thigh & across his groin area. They want us to have him checked for a staph infec. & see a Vascular Surg. tomorrow plus whoever else our Primary Dr. "thinks" he should see! This is UNREAL! The pain wakes him up all night long, & pain meds will NOT even touch this type pain! I have just never seen anything like this! The pain started right after he was brought back to his room, the nurse gave him a pain pill, made him walk for 30mins, then shipped us out the door! He is only 50yrs old. And, now he is NOT even able to WALK! I have NO CLUE what has happened! NO-ONE will ANS us!
Kath, Georgia, USA, May 16, 2012

• Kath in Georgia -- When you say "this device", which device do you mean?? And what was the procedure? An angiogram, angioplasty? Was it for the heart or the leg or some other area? Finally which leg (right or left) was used for the catheter insertion and which leg is the one in pain?
Angioplasty.Org Staff, Angioplasty.Org, May 16, 2012

• SEVERE PAIN! My Husband had this procedure done less than 2wks ago. The day he had this done with this device, he started having "SEVERE" pain in the opposite LEG! When the Nurse called to check on him from the Hospital, I explained all this to her, she said it was NOT normal & to contact the Dr. which I did! When we went back for the follow-up 2 days later & told him this, HE SAID: "I NEVER TOUCHED THAT LEG"! And completely dismissed it/us!!! NOW, my husband can barely walk, his leg/foot swells, SEVERE pain when even sitting/laying down/walking. Unable to bend, pick his leg up, etc...And, NOW I am on the search for some KIND of ANSWER! I can NOT get anyone to tell me anything! He had 2 stints [stents] put in back in 2009, at a Different Hospital/Different Doctor/Different Closure! And, NEVER HAD ONE PROBLEM! Now, I do not even know how he is going to be able to work much less WALK!!!! IS there "ANYONE" who KNOWS "ANYTHING" about what is going on, here?????? PLEASE, HELP!!!!!!!!!!!!!!!!
Kath, Georgia, USA, May 16, 2012

• It's more than two years since I had a catheter angiography to rule out an AVM in April 2010 (see my previous post on July 13, 2010) and thins have not improved. A nerve conduction test in December last year finally proved that my femoral nerve was damaged when the StarClose clip was inserted after the angiography and next week I am seeing a pain specialist, as I am still unable to sit normally and also frequently wake up because of pain (bending my right leg at the hip and at the knee at the same time causes something to tense, aggravating the pain, and this is difficult to avoid when asleep). I've tried various pain medications over the past two years, none have been good. So I ask, does anyone have experience of a nerve blockade to treat femoral pain, as that seems likely to be in my future?
Sara, Southern Finland, May 14, 2012

• Femoral site Catheterization done on 5/25/12 angiogram Mynx closure device failed 11 hours later at home. right groin area swelled up the size of large grapefruit in one minute and testes and penis swelled triple in size and black in color, (I'm Caucasian) went to emergency ultrasound showed I had a pseudoaneurysm of right femoral artery at entry point. The pain was 10 on scale of 1 to 10. will never ever use Mynx again. Philip still in pain.
Fearless Phil, Retired Gas Worker, Burbank, Illinois, USA, May 5, 2012

• Sylvia in Texas and Sherrie in Pennsylvania -- We would normally suggest seeing a neurologist, which you have done Sherrie, and without resolution for your problem. As we've noted, the femoral nerve runs right alongside of the femoral artery and occasionally can be traumatized during a catheter-based procedure from the femoral approach. Read our post from January 14 for more info and also where to report an adverse event. Patients can do so directly. We believe that physicians often do not report these complications, mainly because they never find out about them.
Angioplasty.Org Staff, Angioplasty.Org, April 30, 2012

• I had a Starclose used after a cardiac cath. I began having pain in my groin area for weeks which required elevation and ice for any relief. I also began having pain down my leg. From what I have read about sciatic nerve pain, it fits the exact symptoms. It has been a year now and the pain is alleviated temporarily until I do something to aggravate such as standing for long periods.( ex. cooking dinner) The Surgeon who performed the Cardiac Cath ordered an ultrasound and was happy to report that the artery was not bleeding. Well that is great news except that I still am suffering from debilitating pain. Has anyone else had this problem? With or without the Starclose? Could the damage to the femoral artery also create the same symptoms as sciatic nerve? could the nickel titanium in the Starclose be aggravating the nerve? Could the nerve have been damaged during the procedure? and what can I do to get some help with it? What kind of Doctor should I consult about it? Any feedback would greatly be appreciated.
Sylvia, Austin, Texas, USA, April 30, 2012

• I had a Uterine artery embolization in July of 2011. My doctor used the Star Closure device on my femoral artery. I am still feeling leg pain and burning in my right groin area. I went to a neurologist and he did a nerve conduction test that came out normal. I have issues when I wear tight fitting clothing. Is there a fix for this issue or do I have to put up with it for the rest of my life??
Sherrie, Langhorne, Pennsylvania, USA, April 20, 2012

• Marg5 in United Kingdom -- Sounds like there may have been an intrusion of the collagen plug from the Angio-Seal into your artery. We've seen posts from other patients where this has occurred. But we can't give medical opinions, especially long-distance. You should see a vascular surgeon and see what he/she recommends.
Angioplasty.Org Staff, Angioplasty.Org, March 30, 2012

• In October 2011, i had an angiogram with Angio-Seal device [groin] at noon. Same day, early evening, my leg and foot became really cold. No pulse felt on the leg. Emergency admission and scan showed a V-shaped protrusion into the artery wall. Surgeon gave me heparin fro several days and discharged me. He did not want to operate then as i was pending heart valve surgery. I now have had that and i have an appointment with a vascular surgeon in 2 weeks time. My questions to the Forum:What has happened? What can be done? What are the risks and what questions should i ask. I am particularly concerned about [1]risk of circulation failure in the future/potential loss of limb? clotting? and [2] the prospect of operation on a main artery and bleeding, perhaps fatally, or clotting? Scan showed main artery divides into two - one of the two branches had the V-shaped blockage that reached to the middle of the artery. When i have tried to get information from the cardiologist and the cardiothoracic surgeon they have been reluctant to say anything - 'We are not cardiovascular surgeon' was their reply. Clearly the procedure has been messed up. But where to go from here? Any thoughts please? Thanks.
Marg5, United Kingdom, March 28, 2012

• I had heart cath done on 3/20/12 and I too wasn't aware until 2 days after the procedure that they put the Mynx device in my groin. Having excessive pain in the area with no bruising or lumps. Headaches, nausea and chills. Called the cardiologist and was told no one has ever had these symptoms so it couldn't be from the procedure. Had to have heart clearance for surgery on my colon....hurt too bad now to have any surgery.
tycatdog, Hornersville, USA, March 27, 2012

• I was in a motorcycle accident in Las Vegas on March 3, 2012 and was admitted to the hospital for severe bruising and also had some internal bleeding on my left hip. The doctors chose STAR CLOSE to fix the bleeding. They went in through the right groin. I left Vegas and flew home to Cold Lake Alberta on March 5th. I was off work until March 20th but went back with still some pain. The bruising has subsided but I am still having sharp pain in my left hip. Is this normal? The entrance area from the star closure is not a problem at all. That healed well. It just seems to be the area where I assume the bleed was. A lot of the pain is in the fatty part of my hip and in the joint/or leg crease. I have a family doctor that has never heard of the procedure , therefore he is reluctant to do much for follow up until he sees some medical records from the procedure( which he hasn't been in a hurry to get). I was very impressed in the care I did get when I was admitted, just wishing I had as good of care here. Any help or suggestions would be great.
Colleen Alberta, Cold Lake, Alberta, Canada, March 25, 2012

• Fran in Los Angeles -- See our response from February 12, 2012.
Angioplasty.Org Staff, Angioplasty.Org, March 17, 2012

• I had angioplasty with a 6 French Angio-Seal device placed in my groin afterwards back in late 2006. I have to go for a pelvic MRI soon and was wondering if there is any residual metal from such seals that I have to worry about? Thank you.
Fran, Los Angeles, California, USA, March 13, 2012

• I have also had the pleasure of having that Angio-Seal placed after a heart cath was done, upon going under i was told you will have this which was the pressure method or the seal, i was never given a choice, i think again this is because we have good ins, and they were assured that they would be paid, after the cath was done i was returned to the room, and was told they i would be ready to leave in a hr or so, i laid in the bed looking at my hubby and said is this for real, the doc had stated earlier that medicaid and medicare don't allow prolonged stays, and i needed to be gone as quickly as possible well i was furious, my hubby is retired army and we have tricare, after a hr or so i got up and went to the bathroom to dress, instant pain so undesirable i was at a blank my hubby come thru the door and saw that i was froze he pulled the bell and people ran like in a marathon, turned out that i had a blood clot in the leg that they had done the cath in (groin) area, to this day almost two yrs later i still have problems with this area pain, and discomfort i was advised by my PCP to get back up with the Dr that had done the cath, why is it that no one seems concerned about this?
t davis, mother, Batesville, Arkansas, USA, March 10, 2012

• mismar301 in South Carolina -- If you read through this Forum Topic, and the related one on Complications from Femoral Site After Angiogram, you'll find a number of patients posting similar stories. None of these complications are "normal", but it is estimated that around 4-6% of femoral procedures have access site complications. Although most are minor, we, and several cardiologists we have spoken with, feel this number may be under-reported. As for allergies, Angio-Seal does use collagen as well, which some people are allergic to -- hence the rash. As for pain, sometimes the femoral nerve can get traumatized, sometimes nicked. This may resolve over time. What you need to be careful of is any bleeding complications or possibly an infection. Doesn't sound like either of those, so hopefully over time this discomfort will pass. But if it doesn't, let your cardiologist know. This is one of the reasons Angioplasty.Org has been advocating wider use of the radial (wrist) approach for catheter-based procedures.
Angioplasty.Org Staff, Angioplasty.Org, March 7, 2012

• I had a cardiac cath done on 2/13/12. An Angio-Seal was used to close. I have been having problems with my right leg and the insertion site since. For the first 2 weeks I had a recurring rash that came up every 3 or 4 days. For the last week and a half I have had recurring chills and nausea. I went back to the doctor 4 days after the cath and reported the pain in groin and hip and rash and was told it's normal, but they had no idea what the rash was and sent me home. I went back to the doctor yesterday reporting the continued pain in groin area when I walk or sit. My blood pressure was elevated and I felt a bit dizzy and nauseous They said the pulse was fine in my leg, the blood pressure was fine, and they have no idea what might be causing the pain. Perhaps the femoral nerve was nicked. Is this normal? Could some of these be allergic reactions to the Angio-Seal? This is my second invasive medical procedure in my whole life so I have no history to go on here.
msmar301, Clover, South Carolina, USA, March 7, 2012

• Last April 2011 underwent a cath, was not told about the "Star Closure" til after the procedure If I had been told I would have told them no, as when I was younger I had trouble with IUD's, so I know I have no tolerance to metal no matter how small. Anyways since the procedure if on my feet too long or I am very active I get a terrible cramp like feeling in the groin area, to the point I have a pronounced limp. Went back to my surgeon, they did on ultra sound and referred me back to my reg dr. they are stating that it is not from the clip they used must be related to something else. I have a HARD time believing that. These dr's really need to inform their patients BEFORE the cath about what they are doing and leaving in your bodies. This new condition is a terrible thing not only am I active but I am a waitress /bartender so it is interfering with my job. There must be some sort of legal recourse we can take.
Realsuzie, Connecticut, USA, February 25, 2012

• Has any one seen issues with Boomerang closure device in the arm [brachial] approach??
Suzy, Rockford, Illinois, USA, February 15, 2012

• Bess from Maryland -- We're sorry to hear about your problem. We think that metal allergies from cardiovascular implants are underreported and not well understood. We have a Forum Topic on Metal Allergies, as well. One problem is that the use of vascular closure devices do not require the patient to sign a separate consent form -- they are considered to be part of the general procedure (angiogram or angioplasty). Of course, it would seem that the cardiologist who does the procedure should discuss this with the patient ahead of time, especially in your case. For example, in Abbott Vascular's "Instructions for Use of the StarClose SE Vascular Closure System", it is clearly stated that the StarClose "is contraindicated for use in patients with known hypersensitivity to nickel-titanium." Of course, the doctor would have to ask the question as to whether you have a nickel allergy, and this is unfortunately NOT stressed enough in the pre-exam questionnaire. As for MRI safety, there are very specific instructions on MRI strength (3 Tesla) etc. in the same document and, if your physicians are concerned about this, they should contact Abbott for support.
Angioplasty.Org Staff, Angioplasty.Org, February 12, 2012

• My vascular doctor used a StarClose device during my renal artery angiogram. He never talked to me about it or asked if I was sensitive to nickel which I am. I broke out in an itchy rash the next day and was put on 10 days of Prednisone and diphenhydramine. He told me there was nothing else that could be done because the artery closes over the device. I have suffered for 2 years now from constant pain, itching and numbness at the site. As a RN I am furious I was not informed about this before it was implanted. Does anyone know the long term effects? I worry about the integrity about the arterial wall. Also, I needed an MRI of my spine and 2 radiologists refused because even though Abbott says Star is MRI safe they say there are too many restrictions and potential dangers. The MRI tech said she would be terrified to do the scan even if the radiologist had ok'ed it.
Bess from Maryland, Centreville, Maryland,USA, February 11, 2012

• Gayle in Wisconsin -- Read our post from January 14 and definitely report this issue. As for the 1% figure, we had noted "low single digits" -- it's more like a 3-4% complication rate, but this is as reported and many cardiologists we have spoken with believe the complication rate is higher than that.
Angioplasty.Org Staff, Angioplasty.Org, February 9, 2012

• on 2-2-12 I had a StarClose SE used after heart cath for femoral artery right side, it will be one week tomorrow and I have had severe leg cramps enough to make my leg buckle out from under me and chronic groin and leg pain, which woke me up 3 times last night, I ended up speaking with the nurse as of course she is the contact person who basically informed me that the pain is my fault for not getting up and stretching - what??? the first surgery I had was done 4-10-10 and a Angio-Seal was used wow, I wish I could of told them to only use a Angio-Seal but how do you know? And 1%? of patients end up with issues I think you need to look at those numbers again, what does it take for something to get done? something serious? there must be something that can be done as like I said the first surgery was problem free.
gayle, Wausau, Wisconsin, USA, February 8, 2012

• I just had my 15th stent placed 2 days ago. I have had even more procedures and I have never had pain in my groin area or leg until they used the Mynx. I'm even having pain in my stomach it hurts to walk, it's like a really bad pulled muscle. Yes it was nice being able to get out of bed after 3 hours but this pain does not make it worth it. My previous angio was through my wrist and was wonderful as far as procedures go. Have no idea why my doctor decided to go thru the groin when I was prepped for the wrist. Have decided if pain doesn't get better in 24 hours will call doctor but from sound of things there is nothing they can do.
Patty, Sherwood, Arkansas, USA, February 3, 2012

• Anyone know if there is a class action lawsuit?
Angio Seal Patient, Fort Lauderdale, Florida, USA, January 25, 2012

• To all posters in this topic -- there can be complications from any medical procedure. There are some specific to the femoral artery access for catheter-based procedures, and for those, see our related Forum Topic on "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty". There are also some (a bit different) encountered in the use of vascular closure devices. All of these are low in percentage (low single digits) but they are certainly important if that complication is you. One issue seen in vascular closure devices, such as Angio-Seal or Mynx is the infiltration of the clotting agent (usually some form of collagen) into the bloodstream. This may explain some of the claudication problems, although some of those may be the result of the catheter itself dislodging some plaque, and they have nothing to do with closure devices. Another reason for ongoing pain is trauma to the nerve -- the femoral nerve lies alongside the femoral artery and so, it can sometimes get traumatized or nicked, causing pain. We have heard of a few instances where the nerve itself gets trapped in the closure device (e.g. StarClose). These are all reasons why here at Angioplasty.Org, we have championed the increased use of radial (or wrist) angiography and angioplasty. This access method has less complications although they do exist (you can read other patients' comments on our Forum Topic about "Radial Access"). We recommend to all patients experiencing such complications to first report these to your interventional cardiologist -- the one who did your procedure. It is highly unlikely that such severe and pointed adverse events coming immediately after a cath procedure have nothing to do with the procedure, and it is important that the cardiologist know about such complications. Other specialists who have provided help to patients on these Forums are vascular surgeons or neurologists (where the nerve is involved). If you feel a device has caused a problem, you can also report it directly to the FDA's Adverse Event Reporting system at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
Angioplasty.Org Staff, Angioplasty.Org, January 14, 2012

• Hello, I had an angiogram in 2009 was not told about the Star Closure being a part of the procedure. I've never stopped being in pain. I would like to know if this could cause a life threatening situation given it's connected in my blood stream?
Yolanda, International, Saginaw, Michigan, USA, December 14, 2011

• I had a heart catheterization on 11/18/11. I had to go back today 11/22/11 due to severe claudication in the leg where the Mynx closure device was used. The doctor asked me when it started - duh - the day after the catheterization. I can't walk more than 3 or 4 steps before I have to stop. Now they are scheduling surgery for next week. I guess this is to "fix" whatever they "did" when they put the Mynx in.
ph56 Virginia, Virginia, USA, November 22, 2011

• ON 10/28/2011 I HAD A CARDIAC CATH, SEALED WITH ANGIOSEAL, AFTER FAILING A STRESS TEST 10/27. THE CATH WAS CLEAN. THE DAY AFTER THE CATH I REMOVED THE DRESSING AND HAD EXCRUIATING PAIN FROM THE CATH SITE DOWN THE LEG. THE FOLLOWING WEEK AFTER SHOPPING AND SHOWERING I NOTICED MY LEG SWELLED UP. THE FOLLOWING DAY THE SWELLING WORSENED AND I WAS SENT TO ER TO CONFIRM A BLOOD CLOT IN L FEMORAL VEIN. I WAS PLACED ON LOVENOX Q 12 HRS AND COUMADIN. HAD ANOTHER ULTRA SOUND AND IT CONFIRMED 2 DVT'S. ONE IN SAPHRENOUS VEIN AND ONE IN FEMORAL VEIN. WENT TO VASCULAR DR WHO ADVISED ME TO STAY ON COUMADIN X 6 MONTHS, AMBULATE AND WEAR COMPRESSION STOCKINGS. THAT NITE PAIN STARTED IN THE GROIN AREA DOWN LEG. SHARP PAIN WAS EXTREMELY SEVERE WHEN AMBULATING OR PUTTING PRESSURE ON THE CATH SITE LEG. TODAY STILL PAINFUL BUT I AM RESTING. I AM TO RETURN TO WORK TOMORROW AND I AM VERY NERVOUS. DOES ANYONE KNOW WHAT COULD BE CAUSING THIS?
SHARON, RICHBORO, PENNSYLVANIA, USA, November 20, 2011

• I posted on 10/16/09, 12/7/09, and 4/30/09 regarding the problems I had (scrotal hematoma) with the Mynx Closure Device. I would say that now, over 2 years later, I am at 95% plus. I believe after an injury like this, when the blood reabsorbs into the body, and the swelling goes down, it does not return to "exactly" its normal state or "look". Although I do most activities (run, walk, golf, etc), there are still some activities that do present a problem (bike riding, some sitting positions/chairs, etc). I guess the good news is that my heart is good shape and I will be going to my cardiologist tomorrow. I did note that there were many others on this site with complications from the Mynx.
Lewis M, Bergen County, New Jersey, USA, November 2, 2011

• I had heart cath 7 days ago. When it was over My Left thigh felt like someone was sticking needles in it. It was horrible. They went in through the right groin. Now I am still experiencing this and don't understand why. They also did ultrasound on legs for clots. Chest x-ray and some test with this machine that I had to inhale radiation through a mask. This machine seemed to be some kind of CT scan but I did not go inside it. It had a big square thing that rotating around my upper body. They said no blockage no blood clots. No explanation for horrible chest pain going through to back. This all took place on a weekend trip Asheville NC. Will be seeing my doctor in 2 days. I just don't understand why the left leg is the problem?? Everything I have read people have problems with the groin of entry. The nurse tried to say it was razor burn and didn't believe the pain. I had to say listen I'm not crazy or imagining this. My husband and daughter where very upset at the nurses attitude as she tried to blow me off! Well I sure don't think what I am experiencing burning prickling and pins sticking in my thigh are razor burn a wk later. What do you think??
KC out of town heart cath, Dorchester, South Carolina, USA, October 30, 2011

• Carolyn in NC -- We are so sorry to read stories like yours and the many others posted about problems with caths or angioplasties performed from the femoral approach (almost 1,400 in this topic and the related topic on "Complications from Femoral Site Cath"). While the reported complication rate is relatively low, in the low single digits, even 1% of a million comes to 10,000 stories. Vascular closure devices, like Angio-Seal, are part of the procedure -- therefore in most hospitals, the patient does not need to sign a consent form specifically for the vascular closure device. It is used as per the protocol in that hospital. A patient could conceivably insist that such a device NOT be used. But it's important to understand why they are used. With certain patients and in certain procedures where anticoagulants are necessary, stopping the bleeding from the femoral puncture site can be challenging. Manual pressure has to be applied for a long time -- and this manual pressure can also cause complications. Vascular closure devices were invented to shorten the time needed to safe ambulation (walking) but they have their own set of complications, again very low. All-in-all, in fact, catheterizations from the femoral approach are a pretty safe procedure -- not, of course, if YOU happen to be one of the complications! As for Angio-Seal, one complication is that the collagen or suture material may migrate into the bloodstream, causing a clot. This may be what happened to you. All of these issues are one reason that Angioplasty.Org has been evangelizing for the radial (wrist) approach. While there are complications with any procedure (and you can read about patients' experiences with the radial approach in that topic) the wrist approach has far less complications -- and no vascular closure devices are used! The insult to injury, of course, is that you had no coronary artery disease and, yes, stress tests can often give false positives, especially in women. Another reason why Angioplasty.Org has been a vocal proponent of Cardiac CT scans. When used appropriately, this non-invasive diagnostic scan can correct a false positive stress test (they are 98-99% accurate for ruling out coronary blockages).
Angioplasty.Org Staff, Angioplasty.Org, October 28, 2011

• On Oct. 13, 2011, I had a heart cath because of an abnormal stress test. As a result, no abnormality in my heart was found. However, two days after the cath, I had pain in my right groin near the site of the incision when I walked. The cardiologist who performed the cath was out of the office. An associate cardiologist sent me to the hospital for an ultrasound. (A long hard lump had formed at the incision site). The ultrasound showed a large blood clot in the vein not the artery. The clot (DVT) ran from the middle of my thigh to midway down my leg below my knee. The cardiologist recommended a Greenfield screen be put below my lungs in the vena cava which I had done. I was in the hospital for 5 days. I can feel the screen and am now on Coumadin. The Angio-Seal was used as a closure for the artery during the cath. Was this blood clot related?? The whole thing was unnecessary because of a false reading on the stress test. I have been in good health, never smoked and am normal weight. I am beginning to wonder about the angio seal. I was never told that it would be used.
Carolyn in NC, Wilmington, North Carolina, USA, October 23, 2011

• Steve in Commack -- it is possible that the femoral nerve got nicked or traumatized in some way during the cath (the femoral nerve lies directly alongside of the femoral artery). This may take some time to normalize. If you read through these posts (search the word "nerve" using CTL-F or Command-F) you'll see that a number of patients have experienced this problem. If you or your PCP think this is your problem, a neurologist may be able to shed more light.
Angioplasty.Org Staff, Angioplasty.Org, October 21, 2011

• I am a 51 yr old healthy male and had an angiogram done on 6/9/2011. I came home with extensive black and blues on my right upper thigh and groin area. I went back to the hospital a week later for a sonogram of the area because I was in so much pain. Came up negative. It is now October 2011 (4 months later) and I've been back to my cardiologist, the hospital again, my PCP twice, had a CT scan done of my groin as well as another sonogram and still nothing. I've been out of work now 2 weeks and cannot even barely walk without that area knotting up. No one seems to have an answer as to what is going on. I just spoke to my cardiologist today and he said that it "needs more time to heal and to take Tylenol for pain. I don't know what to do. I am a driver by trade and this pain is making it impossible to perform my job. Does anyone have any advice?
Steve, Commack, New York, USA, October 19, 2011

• My husband had the angio seal put in after his coronary stents. When he was moved to his bed after the procedure the nurse probably grabbed it, and a while later there was blood all over the sheets and his legs. The next morning he had a hematoma the size of a football which instantly filled up. His blood pressure dropped to 50/25 turned grey and passed out twice. With 35 minutes of pressure and kneading the nurse got it down. Then they discovered the next day a vein clot and started Coumadin and heparin to dissolve it. At 2.1 INR he was sent home. In the doctors' office after a Doppler they discovered a pseudoaneurysm. In repairing it they caused a clot in the artery and sent him to the hospital with more heparin and Coumadin to dissolve it. He feels this all started when the nurses moved him roughly to his hospital bed from the operating bed and probably dislodged the angio seal.
Jay, Bloomfield Hills, Michigan, USA, October 16, 2011

• D. Koenig -- Not sure what the pain is. 5 months with no pain and now pain at the site. I would contact your cardiologist (who did the procedure) or possibly Abbott Vascular in Santa Clara CA -- they have a help line that may give you info.
Angioplasty.Org Staff, Angioplasty.Org, October 16, 2011

• On June 9, 2011, I had an Aortic Arch Angiogram which used the StarClose closure device. I had a quick recovery with no problems. But, two weeks ago, I joined a gym and started exercising with weights. This week I notices pain at the area where the StarClose is located. It is a different pain that the normal pain of sore muscles. Is that normal? Should I have any restrictions for exercise?
D. Koenig, Milwaukee, Wisconsin, USA, October 15, 2011

• Michelle -- you should definitely report this occurrence to the FDA's Adverse Event Reporting system at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm It sounds like the StarClose may have entrapped or traumatized a nerve. Have you seen a neurologist??
Angioplasty.Org Staff, Angioplasty.Org, October 10, 2011

• not sure where to begin i had a heart cath April 2010 ever since then i have had nerve damage to my right leg a blood clot i have been to the ER too many times to count and apparently they tell me the star closure device they used failed so therefore the doc that did it says i will have nerve damage .. but when i started having trouble he didn't want to see me any more i never seen him not one time since the procedure he had his nurse practitioner see me in which she was no help i went to my family doc and he sent me to a specialist at Cleveland clinic i have went through total hell from this i can not run or jog i cannot sit for very long and riding or driving for long periods is just totally out of the question .. i am miserable i do not know what to do i am 43 years old and i feel like he and this device has ruined my life.. this procedure was done in Indiana where i am from.
Michelle, Florida, USA, October 2, 2011

• To all posters in this Forum -- anyone who has had a negative experience with a particular device should report this event to the FDA at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. One of the very first devices, VasoSeal, had a much higher than normal complication rate and was taken off the marke. But the FDA only knows about these events from voluntary self-reports from manufacturers and doctors...and patients. So make your voice heard!
Angioplasty.Org Staff, Angioplasty.Org, October 1, 2011

• Had a heart cath done on 9/15/11. The Angio-Seal was used as the closure device, which of course I was not aware of until I received the brochure after the procedure was over. After the procedure I felt fine until they told me I could get dressed to go home. When I got our of bed, my right leg (the leg used for the cath), felt extremely fatigued, as though I had just finished a 20 mile marathon. The left leg felt normal. I remember mentioning it to the nurse, but she thought it was just the lidocaine that was used for the anesthetic and dismissed my complaint. They got a wheelchair to take be down to meet my ride home (normal procedure), and I remember saying that it's a good thing they had a wheelchair because there was no way I could have walked to the elevator. Since the procedure, I still have extreme fatigue in my right leg and can walk no farther than perhaps 40ft without stopping to rest. Oh, and the heart cath showed no heart problems whatsoever. I called my cardiologist and he ordered an ultrasound, but nothing has been determined and he wants to see me in a month. Also feeling just not well...like a lite case of the flu. Felt fine before procedure. What do I do now? I'm 57.
Kathy, Quincy, Illinois, USA, September 21, 2011

• I had a cardiac cath about 5 days ago. I have a lump the size of a quarter that is hard to the touch and painful when touched. I had trouble walking and still limping a bit. They used the Mynx closure device . I also have a huge bruise in the area. I'm hoping this lump eventually resolves. The literature does say up to 30 days to completely dissolve so I'm hopeful . Anybody else with this experience?
alank, Jacksonville, Florida, USA, September 21, 2011

• Hi. I'm 32 yr old female. I had a heart cath with angio seal 2 1/2 years ago. My right thigh where I had the cath in has problems from time to time. For the past three days the outside of my thigh, and around the groin area burns. It is sensitive to touch, almost like a sunburn or rug burn. Should I be worried?
THIGH BURN-ANGIO SEAL, Houston, Texas, USA, September 18, 2011

• 3/30/2011 I had a cath. discharged with large lump which I brought to attention of nurse twice who never checked. Several days later in ER with extreme pain, drained lump, Ultrasound, antibiotic and referred to Cardiologist performing procedure. Couldn't get in to see him, saw regular cardiologist two days latter, who referred that day to interventional cardiologist, to infectious disease specialist, to hospital and the next day right femoral artery repair. In hospital one week, home with wound vac three weeks. Loss of pay and co-pays over $15K. Negligence and more. Do not hesitate to get help, can save your life. Question everything and have a witness.
NV, Jupiter, Florida, USA, August 30, 2011

• I finally had surgery to repair RT Femoral Artery, which was blocked with a Perclose device post angioplasty. 1.5 inches of Femoral artery had to be cut off and replaced with 1.5 inches of another vein. The doctor indicated that the Femoral artery above the blockage had bubbled up close to being an aneurysm. I have a 6" incision in my groin area, the swelling is generalized all over the area, my testicles look like goose eggs, but I am "painfully" happy to be alive and to have taken care of this at this time. It is amazing to me that the medical profession uses these Perclose devices when the error ratio is so large. Do the manufacturers know about this, what are they doing about it?
FJR, Miami, Florida, USA, August 23, 2011

• Diana C in California -- was this a coronary angiogram where the catheter was inserted via the femoral artery in the leg -- or was this an angiogram of your leg, checking for blockages in the leg (peripheral) arteries?
Angioplasty.Org Staff, Angioplasty.Org, August 20, 2011

• I had an angiogram on my right leg on July 2011, and recovery was ok, but I started having pain 2 weeks ago. I would like to know if is normal or I have to go to ER again?
Diana C., Hawthorne, California, USA, August 17, 2011

• Cindy B. in Washington state -- the FDA maintains an adverse event database. While it is our (and many cardiologists' opinion that many adverse events in the area of vascular access site complications are not reported, this link should provide you with a starting point: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
Angioplasty.Org Staff, Angioplasty.Org, August 17, 2011

• My 84 year old mother had a heart cath in April 2011 which was closed with a Mynx device. She was sent home approximately 2 hours post procedure only to have a major bleed at the site of the Mynx. Being a nurse, Mom called 911, was taken to the ER, and had an emergency surgery with a vascular surgeon. She has had nothing but pain and weakness and severe bruising at the site and is getting the run-around by the cardiac doctor. The range of motion of her knee is greatly affected. She is now four months post surgery and a recent MRI showed NO blood clot which is a major concern. Has there been any, and where do I research, for any recorded failures of the Mynx device? Thank you for your information.
Cindy B., Lacey, Washington, USA, August 14, 2011

• Hello all, I'm a healthcare worker with experience across many Angiography suits/labs across the America and Europe and I've seeing a new trend using a painless vascular device called Exoseal by Cordis. Check the companies website and maybe that might be the answer!!!
Medworld, AMERICA/EUROPE, August 12, 2011

• I am updating my posting back in 2009. I still suffer in pain from that horrible Perclose suture device deployed blindly..at the wrong angle...which wrapped around my iliohypogastric and ilioinguinal nerves!It has been 14 years!!!. I just flew to Texas for an ULTRASOUND GUIDED pulsating radio-frequency ablation of those nerves. That procedure was easy compared to the CONSTANT pain I have been in...That Perclose device ruined my trust in many of the medical procedures,and even dr's who first told me they nicked my nerves..then I called the company and was told to see a vascular surgeon to get it out. Well after 3 years the nerves had been strangled and I was still in so much pain. I am an RN., and have a horse ranch for which we do therapeutic riding for special needs kids and adults. I tried to stay very active but could not do nearly what I used to do.Those doctors put me on every narcotic _which I hated and they didn't help. They wanted to put a spinal stimulator in me ,etc... Unbelievable. Lyrica was the ONLY med that helped that knife like pain,but I can only tolerate a very low dose. I tell every one I know NOT to have these suture devices shot into their groins BLINDLY!!!!!
Donna RN, Perclose victim, Hidden Hope Ranch, Grove City, Pennsylvania, USA, August 7, 2011

• Attention all pain sufferers from suture devices!! I posted my comments 2 years ago....have suffered for 14 years after Perclose suture device was deployed and wrapped around my ilioinguinal and iliohypogastric nerves...I found a doctor in Killeen Texas..Dr. Benjamin Lowry, who developed ultrasound guided pulsating radio frequency nerve ablation. I flew to him and he CURED me of my horrible side and inner thigh pain!!! He is the kindest man who can help you if your nerves in the groin area have been injured by these suture devices or hernia surgery ...or even hysterectomies....I got my life back...and he CARES about his patients...and his staff is unbelievable! His office # is 254-618-1777 and 254-618-1781....at Scott and White Pain Clinic, Killeen, Texas. I am a registered nurse, and tried everything ...what a miracle..please tell him Donna from Grove City in P.A. sent you!! Good Luck and God Bless you all suffering in chronic pain..it is life changing.
Donna H, R.N., Perclose device victim, Hidden Hope Ranch, Grove City, Pennsylvania, USA., August 5, 2011

• My 67 year old father had a femoral artery repaired in the groin area using angio-seal on June 1st, 2011. The wound area began leaking fluid like substance and when contacting the surgeon they said it was normal because there are lymph nodes in that area. On June 13th he was sent to the ER from the doctors office because his oxygen levels were not functioning as they should be. Several tests were done to determine the cause and nothing was found. The surgeon came in and looked at the wound and scraped away some crust and said it looked fine and was not infected. My sister recalls the lung doctor making a comment that he was anemic and his white count was a little high but no mention of anything else. The lung doctor prescribed him a steroid to help with the breathing. Another week late my mother called the surgeon's office again to tell them that there was leaking from the site. They asked what it looked like and they said that's normal we will see you at the next visit. My dad's back was bothering him as well and they said that's because he is favoring that right side because of the incision. On June 24th another call was placed to see if he could be seen but was told they only could move his appt. from the following Friday to Monday. A few hours later blood began running out of the incision site. Taken to ER where a repair surgery was done, a hematoma was found in the incision site and that he was loaded with staph infection that area. They said on Monday they would go back in and place a muscle flap over the area to secure it. On Saturday morning it ruptured again and he was hemorrhaging Blood pressure dropped to 54/32 and quick action was taken to save his life. A bypass was performed in that area. Several days later there was no blood supply to his lower leg still. Next step, amputation above the knee. Several days after that surgery he began gasping for air..we were told they were panic attacks but soon found out it was a possible pulmonary embolism. Moved to ICU where he laid for 8 days struggling to breath(fluid). Finally a chest tube was to be placed but on the same day he had already fell into a coma. He was placed on a ventilator and now they are having trouble taking him off. Today, July 30th he is still in ICU and a trache is being place on Monday.
Maureen, Syracuse, New York, USA, July 30, 2011

pa-marie, Pennsylvania, USA, February 12, 2011, This message is for you. If you ever read this forum again I hope and pray you see this. I am 36 yrs old with 12 herniated discs after working for 6 years in an ED as a REGISTERED NURSE. I looked up, how long your leg should hurt after the procedure and found this. What I hear is everyday people discussing things that have happened to them or a loved one and as far as you guys preaching for us to listen and quit smoking and lose weight, just as many of you have the same habits and complaints. I was offended by your post. For the last two years, I have had ridiculous pain and can hardly walk. I had the heart cath done because I have history of cardiomyopathy after the birth of my last child, yes I smoke and yes i am overweight. I understand all the risks!!! However every dr I turn to from the neuro guys, to my PCP nobody can help me. They ALL look the other way and DON'T listen to their patients, maybe some do but I haven't found but 1 that actually paid me attention and it was my cardiologist! Tell me you guys turn the other cheek or turn care over to another underqualified person. How about telling your patients that you JUST DON'T KNOW!
Melissa775, Shelby, North Carolina, USA, July 20, 2011

• I had a cath on 05/13/2011. I already had stents in both legs, This time I thought it was my heart. I went by ambulance to local heart hospital, all was well with heart, but had trouble with right leg right away. Had emergency surgery 6 days later at mayo clinic [Rochester, MN]. The MYNX closure they used completely closed off artery in right leg. I had a 6 hour surgery and 6 inch scar. all together $68,000 med bill. I also would like to know about a class action suit.
Quanyack, Elk River, Minnesota, USA, July 18, 2011

• FJR -- Can't tell you who is financially responsible in your case, but there are outside professionals you might want to consult about this. You've clearly suffered a complication from the use of the Perclose device -- about 1 in a 100 sounds right, although as we have noted several times, many vascular access site complications often are not reported. Total major femoral vascular site complications across all devices and cases where no devices are used (manual pressure) are usually quoted at 3-4%.
Angioplasty.Org Staff, Angioplasty.Org, July 3, 2011

• I had angioplasty and stent placement. Perclose device was used. The procedure blocked 95% of Femoral Artery and I now have Claudication and need additional surgery to repair the damaged artery. I have not been able to start cardio rehab, because the pain as a result of Claudication is unbearable. In addition, this is costing me an additional $10,000 in deductibles and out of pocket expenses. Who should pay for this, the manufacturer, doctor or hospital. How common is this? I have been told it is 1 in 100. We do over 3 million of these procedures every year, is this not a high hit and miss result?
FJR, Miami, Florida, USA, July 2, 2011

• Ken H. from Texas -- what is "this damn thing"? You might be able to get some help if you give some specifics, like name of the product, dates, etc.
Angioplasty.Org Staff, Angioplasty.Org, May 19, 2011

• I'm still looking for help this damn thing that doctor put in me is making my muscles jerk i cant sleep my neck is swollen i have a large lump in my side i have trouble breathing the people who put this out on the market are monsters how will they answer for what they done to people the government covers their ass we are nothing but guinea pigs to them they will have to answer to GOD FOR THIS.
Ken H., Texas, USA, May 11, 2011

• John S. in Florida -- Sounds like they used BioSeal Advanced. You can find more information on the company's web site, including a video of how to use it. We are not that familiar with BioSeal, but it's been approved by FDA. We guess that it's used mainly for outpatient diagnostic caths, where the catheter size is relatively small (5 French or so). That is a change that may have occurred since your dad's earlier caths -- catheter diameter sizes have gotten smaller and the vascular access site is therefore easier to close. Make sure he adheres to the discharge instructions, so as not to disrupt the closure until it's fully healed.
Angioplasty.Org Staff, Angioplasty.Org, May 4, 2011

• My father recently had an outpatient catheterization and they used a weird, brown powder called Bioseal on him. He came out of the procedure and was walking around 90 minutes later. I was concerned because his prior catheterizations had him lying around for several hours. I asked the staff if this was ok and they assured me but it seems too fast. I googled it and it appears to be a product for IVs, what gives? Thanks.
John S., Melbourne, Florida, USA, May 4, 2011

• Jeanne in Georgia -- the StarClose is a nitinol (nickel alloy) clip used the close the puncture in the femoral artery after a cath or PCI procedure. The skin then heals over the clip, which remains permanently on (not in) the artery. What you saw was most likely the small bruise spot where the skin incision was, and a little of the blood underneath. This takes time to go away, and probably has been gone for some time before you noticed or, in this case, didn't notice it. All sounds good.
Angioplasty.Org Staff, Angioplasty.Org, April 22, 2011

• Hello... My mother had a cardiac catheterization in May of 2010. Her cardiologist used the star closure on her groin. When she had it done she had this small blue or black metal spot on her groin... we have just noticed that it is not there anymore. Do these usually come off? or are they supposed to be permanent? It worries me but she doesn't appear to be bleeding. Thanks for your help.
Jeanne, Rossville, Georgia, USA, April 21, 2011

• Recommendations after Angioseal placement (for a diagnostic angiogram) are that the patient can drive after a couple days and resume "normal activity." It actually takes 60-90 days for the complete absorption of the Angioseal collagen and anchor. Doesn't sound like this should interfere with the colonoscopy. You should discuss the hip replacement surgery with your surgeon -- and let the Forum know what you find out.
Angioplasty.Org Staff, Angioplasty.Org, April 16, 2011

• On 4/14/11 I had a angiogram with an angio-seal used. How long a period of time is recommended before having a colonoscopy and also a total hip replacement surgery on the left hip. I am very concerned about the possibility of an infection in my body or risk of the angio seal opening during the hip surgery.
Jude in Texas, Spring, Texas, USA, April 16, 2011

• About 5 years ago I had an angio done on my left femoral artery. I remember EVERYTHING about the procedure, as I was just given a mild sedative. After the Dr was done, he handed the insertion device to the surgical nurse who proceeded to drop the thing on my thigh, over the site. I yelped, and had considerable pain in the groin (felt like a hernia) for a couple of years afterwards. To this day, I cannot have a panty line over that site. Just this past Wednesday, the same Dr. (who I really like) did another on the right leg this time, with no adverse results. I can walk, albeit with a little pain, and no groin pain. The site has only a quarter-sized lump and bruise, as opposed to the huge liver-sized one the first time. Do they make videotapes of these operations? They should.
Theresa from Allamuchy, Hackettstown, New Jersey, USA, March 27, 2011

• Betty from Florida -- you describe the kind of leg pain that a number of posters have written in about, both in this topic and our related Forum Topic on "Complications from a Femoral Angio". The pain may not be related to the Angio-Seal at all, but from trauma to the femoral nerve that may have occurred during the cath procedure. Have you discussed this with the cardiologist who did the procedure? You should, and if it continues, you might want to consult a neurologist, as others on these boards have done.
Angioplasty.Org Staff, Angioplasty.Org, March 8, 2011

• I had a heart cath. done back in Sept 2010. I have been having pain at the insertion site and down my leg since about a week after the procedure. Can any one tell me how long this will last. It seems to be better at times. but if I bend the right leg for any amount of time the pain starts again. Especially in the car or setting at my desk for an extended amount of time. Any suggestion? Help ! ! ! They use the Angio Seal for closure.This was the second one I've had, no problems with the first.
Betty, Fort Lauderdale, Florida, USA, March 7, 2011

• Betsy -- well Mynx is the correct name, but your calling it a Sphynx isn't that far off, considering you have unanswered questions about it, it remains a riddle! If you read over our related Forum Topic on "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty", you'll see that a number of patients report shooting pain down the leg. This is most likely due to a trauma to the femoral nerve (which lies directly along the femoral artery) caused by jostling, etc. during the angiogram. Luckily, this usually goes away, although it may take a while. An angiogram is a very important diagnostic tool -- which is one of the reasons we have been "evangelizing" about the transradial approach, where the catheter is inserted through the wrist artery instead (it's used far more in Europe and Asia, and is gaining in acceptance here in the U.S.). Although no procedure can be complication free, the radial approach, in the appropriate patient, has been shown to have far less complications, especially regarding bleeding, hematoma, and closure issues. You can read more about it in our Radial Access Center -- although hopefully you won't need another angiogram!
Angioplasty.Org Staff, Angioplasty.Org, March 1, 2011

• LOL. I am too funny, yes it was a mynx device!!!! But the hematoma is not black and blue, just a lump, but it has gone down a lot since I posted my first question....however it is still there and this Thursday will be 3 weeks...so I am waiting on it to go away...there is still some residual pain once in awhile, I feel a pain shoot through my leg....I wish I had never had this done.....I think the medical field is "too quick" to do this procedure when other things can be done to check your heart out....this site is great help.....will be giving a donation to help keep it going!! Thanks!
Betsy, Chester, South Carolina, USA, March 1, 2011

• Linda -- the Mynx uses Polyethylene Glycol (PEG) in its application catheter which has a low toxicity, instead of the bovine collagen used in some other vascular closure devices, which patients have reported some allergic reactions to. That being said, the directions for use on the Mynx states that "Mynx Cadence should not be used in patients with a known allergy to PEG." Perhaps you are having a reaction to that. There's also the possibility of an infection at the closure site. If this continues, we'd recommend contacting the cardiologist who did the cath and letting him/her know about this.
Angioplasty.Org Staff, Angioplasty.Org, February 28, 2011

• Can the Mynx device cause an allergic reaction with itching all over, especially, petechial rash which develops into wheals and hives. I have been taking Benadryl 25 mg every 4 hrs. to control the symptoms. Also still having some discomfort in the groin area. The cardiac cath was done 4 days ago. Any information would be appreciated.
Linda, Lexington, Kentucky, USA, February 28, 2011

• Betsy in South Carolina -- we assume you are describing a vascular closure device. There isn't one we know of called a "sphynx", but there is one called the "Mynx" manufactured by AccessClosure (information about it here). As for the swelling and pain and hematoma, do you have a black-and-blue area? That's the hematoma and it sometimes takes days to a few weeks to resolve. The only concern is if the hematoma starts growing in size. We don't think ice would be a problem. Perhaps your cardiologist can prescribe something for the pain you are experiencing.
Angioplasty.Org Staff, Angioplasty.Org, February 26, 2011

• I had a heart cath done about 2 weeks ago. The first couple of days after it was fine, then work on Monday and after sitting all day popped out. Dr. said it was hematoma did ultrasound to check sphynx device used for closure it was okay. I still have the raised bump at the injection site and there is pain there...it has gone down some, but I am still worried and at times, there is pain at the injection site. Dr. just passes it off, says it'll go away. Since it's been 2 weeks, can I use ice and it will help now or not? Thanks...Betsy in South Carolina.
Betsy, Chester, South Carolina, USA, February 25, 2011

• Cardio Angiography. Did not know the StarClose would be used until after it was done. Patients should be informed before having a foreign object inserted. I trust I am receiving top notch care. But I did have numbness in my toes of the access leg. Not warned until discharge. Having cryptogenic stroke make potential numbness a VERY important after effect to be aware of.
RobinOH, Cleveland, Ohio, USA, February 17, 2011

• To read about the underreporting of adverse events (including a death) at one university medical center involved in vascular closure device trials,go to: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm212552.htm. Or request more details through the Freedom of Information Act: http://www.fda.gov/RegulatoryInformation/FOI/default.htm
RN, Winston Salem, North Carolina, USA, February 15, 2011

• Amazing. I'm a PA and just had a cardiac cath done. The culprit was a vasospasm, no blockage. Nothing done by humans is perfect, many of you work, can you honestly say that anything you do in life that is complicated is done perfectly every time? There are risks in EVERYTHING we do in this life! And how many of you listened to the doctor, PA/NP who said - stop smoking, eat healthy, exercise, lose wt., avoid drugs/alcohol, maintain=control your diabetes, high blood pressure, cholesterol, etc? I know, I see you in the office and how you hem and haw about about your obesity and lousy habits yet you look to the medical establishment to "fix" you yet you take little effort to do so yourself. Every procedure out there is designed to help and there are risks to ALL OF IT. It is only doing them over and over again that we try to perfect them and damn it we try very hard to do so! But this is a complicated and difficult task we in medicine tackle. A little help starting with patient compliance with instructions would do. Oh and own up to your own failings..lose the wt,just say NO to fast food, and LISTEN to us and ask questions, learn about your disease process and maybe you'll live better.
pa-marie, Pennsylvania, USA, February 12, 2011

• Ryan in Toledo -- a hematoma (dark black-and-blue bruising and swelling) can take several weeks to disappear, especially if it's a large one. Have you been in touch recently with the cardiologist who did the angiogram? He/she might be able to give you more specific information and it would be useful for the person who did the procedure to know exactly your outcome. Arterial access site complications like yours are a complication of catheterization at the femoral site and yours was significant, requiring surgical repair.
Angioplasty.Org Staff, Angioplasty.Org, February 12, 2011

• I had angiogram 3 weeks ago to test for RAS. Had the lining of my artery torn and pressed together while applying angioseal. realized i had no pulse in my feet in recovery. went back in and had angiogram on other leg. Dr. realized he couldn't repair it that way so he called vascular surgeons. had the damaged lining removed and then they put a "sheath" over the artery so it would not herniate.now i have a 6" incision in my groin and spent a week in the hospital when there was nothing wrong with me to begin with. 2 weeks after i was still in bad pain. mostly on bed rest still. saw the surgeon because i was worried it may be infected. he poked around a bit and opened the wound in one spot. told me it was not infected but gave me antibiotics as precautionary. wound was still leaking fluid and blood next day as well as my penis was swollen. went to er and they said it was a hematoma after they did an ultrasound. said penis swelling would be normal in this situation. now its two days after the er visit and my penis and scrotum are both swollen. still have to change dressings frequently due to leakage. all done at medical college. is this right to still be leaking and swelling weeks after? (This has been cross-posted from the priginal Forum Topic, "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty".)
Ryan, Toledo, Ohio, USA, February 11, 2011

• Peter S in England -- a number of sources states that it is safe to shower 24 hours post-Angio-seal, but that patients should wait a week to take a bath.
Angioplasty.Org Staff, Angioplasty.Org, February 10, 2011

• i have had 4 angio seals with only one that failed, i would like to know, which no doctor has told me, when can i get the seal wet, does it matter if i have a bath or shower straight away or do i have to wait a week or two.
Peter S, retired, Gloucestershire, England, February 10, 2011

• Pat -- Thanks for clarifying. Were these stents placed in your leg artery or your coronary heart artery? If in the leg, check out our topic on peripheral angioplasty.
Angioplasty.Org Staff, Angioplasty.Org, January 27, 2011

• I'm adding to my post of Jan.25. I actually had the Angio-Seal on the second cath. I still have the card I carry. I don't know what the first doctor used. I have found out that I don't have the hypertrophic cardiomyopathy that the first cath diagnosed and I am left with stents and I'm on blood thinner and aspirin. I would have been better off if I'd done nothing!The Angio- Seal on this last cath doesn't seem to be a problem, although I did have pain the first few weeks after in my left leg. I also feel some pain in the stents!
Pat, Fyffe, Alabama, USA, January 27, 2011

• I had a heart cath done on Aug,10, 2010. About a week after, I started having the toes on my right foot turn blue to purple at times. Also when I walked down and then up my long driveway I had extreme fatigue in my right leg. Oct. 28 I had two stents put in my right femoral artery to open a blockage. Don't know if the plug caused the problem or not. Very disappointed in having the stents and taking blood thinner and aspirin! I had the Angio-seal to plug the artery the first time.
Pat, Fyffe, Alabama, USA, January 25, 2011

• PAIN STARTED HOURS after procedure. 7 repeat SEVEN years later I am still in pain! Procedure 12/23/2003.Nurse told me never heard of the pain before. Why didn't I do anything then? because less than 2 months later I underwent treatment for breast cancer. Due to complications during treatment & recovery it was not a high priority, but now the pain is becoming more frequent. I live in enough pain every day, i don't need another area causing me pain. I can no longer ride a bike, run, or anything else that aggravates the site.
Chris, Reading, Pennsylvania, USA, January 14, 2011

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