MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX STENT; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number G38483

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2018

Event Type  Injury  

Event Description

Stent failure to deploy.Pulled sheath and stent all together due to stent not deploying.

• Brand Name: ZILVER PTX STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD
• MDR Report Key: 8414045
• MDR Text Key: 138677415
• Report Number: MW5084829
• Device Sequence Number: 0
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Model Number: G38483
• Device Catalogue Number: G38483
• Device Lot Number: C1470184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Is the Reporter a Health Professional?: No
• 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): Required Intervention