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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"phair, 2020, (zilver ptx) ¿ primary patency of long-segment femoropopliteal artery lesions in patients with peripheral arterial occlusive disease treated with paclitaxel-eluting technology.In this retrospective cohort study, a single-center, prospectively maintained database was interrogated to find all consecutive patients undergoing endovascular intervention with paclitaxel-coated balloons and paclitaxel-eluting stents from 2015 to 2018 for long segment (100 mm) femoropopliteal disease.Twenty-eight percent of patients (n = 29) underwent concurrent tibial intervention.This file will capture 29 cases of off-label use: placement of zilver ptx in tibial artery.Patient outcome: twenty-eight percent of patients (n = 29) underwent concurrent tibial intervention.

Event Description

Supplemental report being submitted due to completion of the investigation on 21-apr-2021.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Device evaluation: the zisv6 devices of unknown rpn and lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0118-6) states the following: ¿the zilver ptx drug-eluting peripheral stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 300 mm per patient¿.There is evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause of the user not reading or following the ifu was identified from the available information.From the information provided it is known that the 29 patients had zilver ptx stents placed in the tibial artery.As per the ifu zilver ptx stents are intended for use in the above-the-knee femoropopliteal arteries.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patients underwent concurrent tibial angioplasty.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 11278970
• MDR Text Key: 280446651
• Report Number: 3001845648-2021-00055
• 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
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 12/18/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR