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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

Noory et al 2023 - evaluation of femoropopliteal in-stent restenosis characteristics stratified by stent design.Results the cohort studied included 414 patients with 236 supera stents, 67 biomimics 3d stents, 48 zilver® ptx® stents, 38 smart control stents, and 25 viabahn® endoprosthesis lesions.After stent implantation, the mean time to restenosis ranged from 10.5 8.7 months for smart stents to 18.9 22.4 months for viabahn endoprostheses.The mean time to restenosis was 13.3 7.6 months for the biomimics 3d stent, 14.1 11.6 months for the supera stent, and 16.6 13.5 months for the zilver ptx stent.Freedom from restenosis is shown in figure 3.This file will capture the 13 cases of off label usage of the cook stent used below the knee.Patient outcome: no adverse effects.Patient/event info - notes: zilver ptx group: n = 48; male = 28, avg age = 58.

Manufacturer Narrative

Pma/510(k) # p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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: 18526497
• MDR Text Key: 333485820
• Report Number: 3001845648-2024-00030
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2023
• Event Location: Hospital
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR
• Patient Sex: Male