MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Model Number	G38482
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device: niu stent, superficial femoral artery, drug-eluting.
Event or Problem Description
According to the initial reporter "the stent was implant and looked great upon implantation.Today, the patient was brought back in for the stent to placed in the other leg.However, image review the stent that was already placed ((b)(6) 2022) had completely separated into two pieces." the separated stent is being left in the patient at this point.The physician will be performing an ultrasound (to confirm flow / and possible 'bridging stent' placement - to ensure flow) to decide the best form of subsequent action.Per phone conversation with the cook representative on (b)(6) 2022: the patient's leg was bent when the stent was deployed.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14595668
• Report Number: 3005580113-2022-00065
• Device Sequence Number: 13977148
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)231004(10)C1892648
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/03/2022
• Report Date (Section F): 06/03/2022

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: 10/04/2023
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C1892648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/23/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2022
• Date Device Manufactured: 12/01/2021
• 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: 60 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/03/2022