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

Model Number	G38516
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, from the physician the device failed to fully deploy, and as they were trying to back it out, while partially deployed, it got stuck on the aortic bifurcation and then became detached from the delivery system completely.They ended up have to used 3 more devices to anchor it in place.Pt is doing fine.Outside of a somewhere steep aortic bi-fur, nothing was out of the ordinary.I have the failed device in question, as i stopped by to pick it up.Further information provided - they had access on right side of the patient and were over the bifurcation attempting to stent the left leg.During deployment, roughly two thirds of the stent deployed and one third was stuck in the deployment system.They ended up breaking open the handle of the ptx and attempting to deploy the rest of stent.They were able to get the proximal one third of the stent deployed but it was inside of the introducer sheath that was over the bifurcation.The case is still going on.They are presently attempting to extract the rest of the stent from the sheath.

• 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 rd; national technology park; limerick
• MDR Report Key: 22345588
• Report Number: 3005580113-2025-00033
• Device Sequence Number: 11984136
• Product Code: NIU
• UDI-Device Identifier: 10827002385167
• UDI-Public: (01)10827002385167(17)60329(30)1(10)C2190357
• Combination Product (Y/N): Y
• 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): 06/26/2025
• Report Date (Section F): 06/26/2025

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: 03/29/2026
• Device Model Number: G38516
• Device Catalogue Number: ZISV6-35-125-8-60-PTX
• Device Lot Number: C2190357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2025