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	Improper or Incorrect Procedure or Method (2017)
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
Per rep - (b)(6) 2025 - 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.Update from rep - (b)(6) 2025 - 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.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Cancellation report is being submitted due to the completion of the confirmation received from qe on (b)(6) 2025 file can be cancelled as "as the adverse effects related to (b)(4) were linked to the abnormal use the details of the use error of incorrect size wire guide should be recorded in the pms log." see medical device report with g8 number 3001845648-2025-00311 for the report of the serious injury with this event.
Additional Manufacturer Narrative
Cancellation report is being submitted due to the completion of the confirmation received from qe on (b)(6) 2025 file can be cancelled as "as the adverse effects related to (b)(4) were linked to the abnormal use the details of the use error of incorrect size wire guide should be recorded in the pms log." see medical device report with g8 number 3001845648-2025-00311 for the report of the serious injury with this event.

• 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 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 22904252
• Report Number: 3001845648-2025-00439
• Device Sequence Number: 8001379
• Product Code: NIU
• UDI-Device Identifier: 10827002385167
• UDI-Public: (01)10827002385167(17)60329(30)1(10)C2190357
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P100022/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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
• Patient Sex: Unknown