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

Catalog Number ZISV6-35-125-7-60-PTX

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The intended target site for the device was the right common iliac; however, the device landed further up into the aorta as the user believed it was not well imposed.The user wanted to use a cuff to rectify but the stent was very mobile so they elected to leave it alone.It appeared it would migrate north toward the renal so they elected to not intervene.It is important to note the device was being used off label.Patient outcome: na.Patient/event info - notes: sheath used.Wire guide.Ipsilateral.Right com iliac - off label.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18335069
• MDR Text Key: 330601311
• Report Number: 3001845648-2023-00910
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384870
• UDI-Public: (01)10827002384870(17)250822(10)C2098020
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-60-PTX
• Device Lot Number: C2098020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2023
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1