MAUDE Adverse Event Report: COOK ZILVER; STENT

Device Problem Insufficient Information (3190)

Patient Problems Extreme Exhaustion (1843); Hair Loss (1877); Nausea (1970)

Event Type  Injury  

Event Description

Right after i had the cook zilver implant put into my leg i became severely exhausted, my hair became very brittle, i had natural curly hair, where i lost the curl, i was also very nauseated daily all day long, you can check my medical records that past 2 years and see i had been complaining to my doctor something was wrong ever since i had the stent put in, i was at the doctor continuously, hospitalized due to this, then all of a sudden in (b)(6) i woke up all symptoms gone.I don't know if i was allergic to the medication or what, i have 18 heart stents and i had no reaction to those.I actually thought i was dying.

• Brand Name: ZILVER
• Type of Device: STENT
• Manufacturer (Section D): COOK
• MDR Report Key: 5466487
• MDR Text Key: 39341459
• Report Number: MW5060573
• Device Sequence Number: 1
• Product Code: FGE
• 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: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 62 YR
• Patient Weight: 77