MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635; STENT, ILIAC

Model Number	G43832
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Stent malfunctioned, failed.

• Brand Name: ZILVER 635
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; 750 daniels way; bloomington IN 47404
• MDR Report Key: 18484252
• Report Number: 18484252
• Device Sequence Number: 16825105
• Product Code: NIO
• UDI-Device Identifier: 10827002438320
• UDI-Public: (01)10827002438320(17)250308(30)1(10)C1919552
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2023
• Report Date (Section F): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G43832
• Device Catalogue Number: ZIV6-35-125-8-60
• Device Lot Number: C1919552
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 96 KG
• Date Report Sent to FDA: 08/17/2023