MAUDE Adverse Event Report: CORDIS SMART CONTROL TM ILIAC

Catalog Number C07040SL

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

Event Description

In (b)(6) of 2011, my mother had two cardiac stents placed.After having the stent placed, my mother began experiencing severe chest pain.She found a new cardiologist and was told that she had a blockage in the arteries where the stents were placed.She was told that she needed to have a triple bypass surgery.She had the surgery and suffered a stroke and other avoidable complications afterwards.Now my mother suffers from severe debilitating pain 24 hours a day 7 days a week.After stumbling across a blog and with much research, i've since discovered that the stents and the chest wire that was placed in my mother contains nickel and four other metals that my mother's allergic to.I've found that the allergy results in severe debilitating pain.Not once was it discussed with my mother and i regarding the components of the materials being used.My mother knew that she had a nickel allergy.We were never asked about the allergy and she didn't know to ask.I took my mother to a dermatologist and she tested positive to moderate and severe reactions from the metals in the stents and chest wires.Most people with this type of reaction from the chest wires simply have the wires removed.My mother, who was walking a mile or two before all of this, is now paralyzed on her left side, wheelchair bound, suffers with debilitating chest pain, entire left side pain night and day every day.Her body is so weak now, having the wires removed isn't an option for her.The stents in her heart can't be removed.My mother's dying a very slow and agonizing death.Since all of this, my mother who looked young for her age at (b)(6) when it all started, looks as if she's in her late seventies or early eighties.The doctors blow her pain off and refuse to acknowledge the allergy to the chest wires.Even though it's clearly documented by a dermatologist.I can't find an attorney to help her because she's on (b)(6) and had a disability.I was told that a case wasn't worth much money by an attorney over the phone.That's probably why i was having such a hard time finding someone to help her.My mother has suffered from medical negligence and has been ignored because of her economic status.Where is the justice!.

• Brand Name: SMART CONTROL TM ILIAC
• Type of Device: SMART CONTROL TM ILIAC
• Manufacturer (Section D): CORDIS
• MDR Report Key: 5587797
• MDR Text Key: 43274134
• Report Number: MW5061792
• Device Sequence Number: 2
• Product Code: FGE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/17/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C07040SL
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 67 YR
• Patient Weight: 61