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 05/10/2023

Event Type  malfunction  

Event Description

Bosiers et al 2023 - zilverpass study: zilver ptx stent vs.Bypass surgery in femoropopliteal lesions, 3 year results and economic analysis procedures: standard procedures were followed based on the instructions for use for the devices.Intraoperative heparinization (5000 units) was applied in both treatment groups.The only pre-treatment allowed prior to placement of the zilver ptx stent was standard balloon angioplasty; no reentry or atherectomy devices were permitted.The use of pre- and postdilation was recommended but at the physician¿s discretion.Angiography immediately after the endovascular intervention was required to evaluate the postoperative lesion.Following treatment, antiplatelet therapy consisting of clopidogrel for at least 60 days and lifelong aspirin therapy was routinely prescribed.Physical examination was performed prior to discharge.The follow-up data collection points were 1, 6, 12, 24, 36, and 60 months, with unplanned or interim visits as need for recurrent symptoms or complications.Follow-up visits included abi measurements, rutherford category assessment, and duplex ultrasound examination.This file will capture 113 cases of off-label usage of reference vessel diameter.Reference vessel diameter in article: 4 to 8mm as per row (germany, italy, belgium, brazil) ifu, rvd should be 4 to 7mm no adverse effects 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the zilver ptx treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%).

Manufacturer Narrative

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: 18261249
• MDR Text Key: 329681467
• Report Number: 3001845648-2023-00876
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 05/10/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2023
• 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: 68 YR
• Patient Sex: Male