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 Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

Ye et al 2022 - first peripheral drug-eluting stent clinical results from china: 1-year outcomes of the zilver ptx china study.Methods: patients with a single de novo or restenotic sfa lesion <=140mm and a rutherford classification of 2 to 4 were treated with the des.The primary endpoint was primary patency assessed by duplex ultrasound at 1-year.Secondary endpoints included adverse events, event-free survival (efs), and freedom from target lesion revascularization (tlr).Clinical outcomes included rutherford classification, ankle-brachial index (abi), and the walking impairment questionnaire (wiq).Results: in this study, 178 patients with symptomatic peripheral artery disease were enrolled at nine institutions in china.The average lesion length was 79.0 ± 48.6mm (range 14.8¿245.4mm) and 50.0% of lesions were total occlusions.The 1-year primary patency rate was 81.9%.Covariate analysis revealed that lesion length (p < 0.01) was the only significant factor for patency.No paclitaxel-related adverse events or amputations were reported.The 1-year rate for efs was 94.9% and freedom from tlr was 95.5%.Through 1-year, treatment with the des resulted in statistically significant improvement in abi and wiq scores compared with pre-procedure (p < 0.001).Clinical improvement of at least 1 rutherford class was achieved in 142 of 174 patients (81.6%).In vessels with a reference vessel diameter of 4mm, a 5-mm stent is a good choice, resulting in a patency rate of 84% in this study.In comparison, patency rates were lower (63%) when a 5-mm stent was placed in vessels with a reference vessels diameter>4mm.Further, when 6mm stents were placed in vessels >4mm, the authors report a patency rate of 89%.Thus, reinforcing that a 6-mm stent should be used to provide adequate oversizing for vessels >4mm, consistent with the instructions for use.This file will capture the user error of selecting a 5mm stent for 43 patients having reference vessel diameter greater than 4mm.As per ifu, stents must be at least 1mm greater than the rvd.No adverse effects reported in the paper.Num of patients = 178; 249 stents (mean of 1.4 stents per lesion) were implanted.Male = 40, mean age = 67.4 ± 8.6 years.

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: 18261241
• MDR Text Key: 330016550
• Report Number: 3001845648-2023-00868
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/27/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 12/04/2023
• 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: 67 YR
• Patient Sex: Male