MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO,STENT, ILIAC

Model Number	G43843
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the stent was deployed during a venous stent placement, a piece of the inner catheter broke off.They used a snare to pull out the piece of the broken catheter.There was no delay or additional procedure.No reported adverse effect to the patient.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO,STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick ; IE
• MDR Report Key: 24034674
• Report Number: 3005580113-2026-00005
• Device Sequence Number: 13398532
• Product Code: NIO
• UDI-Device Identifier: 10827002438436
• UDI-Public: (01)10827002438436(17)281016(10)C2356200
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2024
• Report Date (Section F): 01/12/2026

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 Model Number: G43843
• Device Catalogue Number: ZIV6-35-125-10-80
• Device Lot Number: C2356200
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2025
• Device Age: 63
• Date Report to Manufacturer: 12/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 10/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/12/2026