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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Type  Injury  

Event Description

Gray et al 2023 - five-year results from the imperial randomized study of eluvia and zilver ptx drug-eluting stents and the long lesion sub-study for femoropopliteal artery disease.Methods: patients with symptomatic stenotic lesions (rutherford category 2-4) were enrolled in the prospective.Imperial rct (2:1 randomized, single-blind, noninferiority, global, multicenter, n=465) and long lesion sub-study (single-arm study of eluvia, n=50).Effectiveness (primary patency) and safety, including clinically driven target lesion revascularization (cd-tlr), major amputation, and mortality rates were evaluated through 5 years.Results: overall, 75.7% (296/391) of evaluable rct patients completed 60-month clinical follow-up.The cd-tlr rate was 29.3%for patients treated with eluvia vs 34.2% for zilver ptx (p=0.3540).Among patients undergoing cd-tlr, mean time to the first event was longer for patients treated with eluvia; this was significant through 3 years (581 +/- 273days vs 414 +/- 234 days, difference 166 days; p=0.0058) with a nonsignificant difference through 5 years (737 +/- 427 days vs 645 +/- 488 days, difference 92 days; p=0.3099).Target limb major amputation rates did not differ significantly between groups (3.4% for eluvia and 2.6% for zilver ptx; p>0.99).All-cause mortality was 20.3% for eluvia and 19.2% for zilver ptx (p¼0.7862).Kaplan-meier (km) primary patency estimates were 69.6% and 67.4% for patients treated with eluvia and zilver ptx, respectively, at 60 months (log-rank p=0.4764).In the long lesion substudy, the 5-year cd-tlr rate was 42.9% (15/35) with mean time to first cd-tlr 876 days (95%ci 630, 1122 days).No major amputations occurred.The km estimate of primary patency at 60 months was 51.7%, and 5-year mortality was 31.0% (13/42).This file will capture 1.6% of 391 patients with a loss of patency not treated by tlr.

• 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
• MDR Report Key: 18275638
• MDR Text Key: 329845374
• Report Number: 3005580113-2023-00123
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2023
• Distributor Facility Aware Date: 11/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• 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
• Patient Outcome(s): Required Intervention