MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; STENT, ILIAC VEIN

Model Number	G38416
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor tried to activate the thumb wheel but was met with tension.He pulled the thumbwheel back harder and forced the stent out, but part of the stent would not deploy.The doctor pulled the delivery system out and half the stent remained in the body, the other half was still in the delivery sheath.The doctor placed a covered stent over the fractured stent still in the body.I have the other half of the stent that was in the delivery sheath and can return the piece.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 17298427
• Report Number: 3005580113-2023-00085
• Device Sequence Number: 14381516
• Product Code: QAN
• UDI-Device Identifier: 10827002384160
• UDI-Public: (01)10827002384160(17)240601(10)C1964590
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2023
• Report Date (Section F): 07/11/2023

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: 06/01/2024
• Device Model Number: G38416
• Device Catalogue Number: ZISV6-35-125-5-140-PTX
• Device Lot Number: C1964590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2023
• Date Device Manufactured: 07/28/2022
• 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 Sex: Unknown