MAUDE Adverse Event Report: BOSTON SCIENTIFIC WALLSTENT ENDOPROSTHESIS

Model Number WALLSTENT ENDOPROSTHESIS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Disability (2371); No Code Available (3191)

Event Date 07/02/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 i had an appointment with dr (b)(6) at (b)(6).He was supposed to talk to me about blockage in my left leg.I had a cat scan done on my leg and dr (b)(6) said that after looking at the film he was 99% sure i would not need a stent.I did not know what a stent was made out of.I asked him and he said that they are made out of metal.I told him i am allergic to metal and have been trying to get it out of my body since 1983.I said i was 100% sure i did not want him to put a metal stent in me.I begged him not to put it in me and i thought he understood me.I went to check for a blockage on (b)(6) 2014 and i was afraid he would put a stent in so i called his nurse (b)(6) and she said she would be sure to tell him not to put a stent in.I did not get to see dr (b)(6) before he checked for blockage.When he finished and took me back to my room he had put two stents in my left leg and one stent in my right leg.Dr (b)(6) told my husband that he had to put stents in both legs and my husband asked him why he put stents in even though he was told not to put stents in because i am allergic to metal.He just left the room and i have not heard from him.I called boston scientific, which makes the stents, and they said that they put on the package that the stents come in says not to put them in if you are allergic to metal and that the dr should have seen this and not put them in me.I didn't know that they put that on the stent package but my granddaughter went online and got the co number and called them and told them what happened and they told her this and they asked her for my number to call me and they told me the same thing.Afterwards dr (b)(6) could not take the stents out because he said the vein tore from being allergic to the metal in the stent and that i almost died from losing so much blood.All he could do was stop the bleeding and sew me up.He cut me from my chest to the bottom of my stomach and i still have the stents in me that are making me so sick and i can't get them out.I went to (b)(6) to dr (b)(6) for a second opinion.He ran tests on me but just said major surgery was the only way to take them out and at my age, (b)(6), i probably would not make it.I was able to work part time before dr (b)(6) put the stents in but have not been able to work since (b)(6) 2014.My husband and i don't draw enough money a month to live on.My husband has copd and can't work and now that i am unable to work we are almost or about to lose our home.We can't pay our bills or buy food and medicine.I have a lawyer but she is telling me that since i did not sign a paper saying that i am allergic to metal, i may not have a case.I can't stop trying to find some doctor who can help me.I will die trying because i can't live like this.My mind is racing so badly that i can't even read or watch tv, my body is stinging like i am in a fire ant bed and my mouth on the inside is burning so bad.I am telling all this in case i don't make it.I hope it will help someone else who is allergic to metal to not let a dr put a stent in because they can't take it out.Please, if you can do something so a dr will have to do something else before they can put stents in people because i told dr (b)(6) and i begged him not to put one in me because i knew i was allergic to metal and he did it anyways.Diagnosis for use: blockage in left leg but not enough for stent.Was not having a problem with right leg.Event reappeared after reintroduction.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 4484064
• MDR Text Key: 5331553
• Report Number: MW5040578
• Device Sequence Number: 3
• Product Code: MQR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WALLSTENT ENDOPROSTHESIS
• Device Lot Number: 16319746
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 70 YR
• Patient Weight: 86