MAUDE Adverse Event Report: COOK MEDICAL INC ZILVER DRUG ELUTING STEND PTX

Catalog Number ZIV6-35-125-7-60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 06/26/2015

Event Type  Injury  

Event Description

Had rt leg amputated (b)(6) 2016 from having cook medical zilver drug eluting stent ptx implanted in rt leg following several operations from (b)(6) 2015 first operation through (b)(6) 2016.

• Brand Name: ZILVER DRUG ELUTING STEND PTX
• Type of Device: ZILVER DRUG ELUTING STEND PTX
• Manufacturer (Section D): COOK MEDICAL INC
• MDR Report Key: 6242998
• MDR Text Key: 64708544
• Report Number: MW5067177
• Device Sequence Number: 1
• Product Code: NIU
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7-60
• Device Lot Number: C1100006
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE.; RX MEDS: MANY
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 49 YR
• Patient Weight: 91