MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG ELUTING PERIPHERAL STENT

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/04/2019

Event Type  Injury  

Event Description

It was reported that two 7mm zilver ptx stents were placed in the patient in 2015.During a post thrombolysis, it was noted that there was flow behind the stent struts and also stent fractures.Drip tpa was administered to dissolve the clot, and a and a 7 x 250 (another manufacturer's) covered stent was placed.The patient outcome was noted to be stable/good.

• Brand Name: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9244884
• MDR Text Key: 179243547
• Report Number: 3005580113-2019-00642
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2019
• Distributor Facility Aware Date: 10/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 78