MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number	ZISV6-35-125-6-80-PTX
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, "procedure was yesterday (b)(6) 2023, physician called this afternoon stating the stent had shut down and that there was going to be another surgery today to see what was going on.The stent deployed successfully during the 1st procedure; post stent angiogram looked successful.Will find out today if the stent failed or something else might have caused the occurrence.".

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 17737854
• Report Number: 3005580113-2023-00108
• Device Sequence Number: 5492791
• Product Code: NIU
• UDI-Device Identifier: 10827002384801
• UDI-Public: (01)10827002384801(17)250330(10)C2062357
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2023
• Report Date (Section F): 09/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Catalogue Number: ZISV6-35-125-6-80-PTX
• Device Lot Number: C2062357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2023
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/11/2023