MAUDE Adverse Event Report: COOK, INC. ZILVER STENT; STENT SUPERFICIAL FEMORAL ARTERY DRUG - ELUTING

Catalog Number 7X100X125

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 07/23/2018

Event Type  Injury  

Event Description

Expired drug eluting stent was deployed and not retrievable.Stent was 67 days expired.Pt stated, understood and was not concerned.No adverse effect to pt.Route: intravenous (not otherwise specified).Dates of use: (b)(6) 2018.Diagnosis or reason for use: occluded vessel.Is the product compounded: no; is the product over-the-counter: no.

• Brand Name: ZILVER STENT
• Type of Device: STENT SUPERFICIAL FEMORAL ARTERY DRUG - ELUTING
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 7784473
• MDR Text Key: 117308681
• Report Number: MW5079153
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Catalogue Number: 7X100X125
• Device Lot Number: C1369414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 50