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

Catalog Number ZIV6-35-125-6.0-100-PTX

Device Problem Fracture (1260)

Patient Problem Occlusion (1984)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s001.(b)(4).Information pertaining to as follows: (b)(4).Importer site establishment registration number: (b)(4).Device evaluation the ziv6-35-125-6.0-100-ptx device of lot number c1143516 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.Images of the procedure were provided on the (b)(6) 2018.Document review prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1143516.As per the product instruction for use, restenosis of the stented artery and stent strut fracture are listed as known potential adverse effects.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression 1.Stent and sfa occlusion from stent fracture is confirmed.The stent fractured where it had been most severely stretched during implantation.2.Other causes of occlusion were unlikely.Had neointimal hyperplasia been a significant problem, it would have been expected in the pre-existing stent particularly given the history of tobacco abuse.The durable left sfa angioplasty also supports stable atherosclerosis.Although the occlusion could have been the result of new atherosclerotic plaque involving the 2.5cm segment distal to the stents, this segment's initial health and lack of disease progression elsewhere, make this unlikely.Root cause review a definitive root cause of stent and sfa occlusion as a result of stent fracture was identified in the image review.Summary complaint is confirmed as the failure was verified in the image(s).Stent and sfa occlusion as a result of stent fracture was confirmed.According to the initial reporter, the patient experienced persistent claudication, but did not receive any further medical intervention as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Following additional information (receipt of images and the conclusion of the image review (09nov-2018)), this event has been re-assessed as reportable.On (b)(6) 2015 during the index procedure the patient received one zilver© ptx© stents.The study lesion was in the right proximal sfa.The lesion status was restenotic and there was moderate calcification but no thrombus observed pre-procedure.The inflow tract was patient and there was one runoff vessel.The lesion length was 60 mm and the proximal and distal rvd were both 6 mm.The percentage diameter stenosis in study lesion was 100 %.The post-procedure imaging showed 0 % diameter stenosis left in the study lesion.On (b)(6) 2016 (182 days post-procedure), the follow-up clinical assessment revealed a study leg rutherford classification of 0.The study lesion status was patent and the patient was still taking aspirin.On (b)(6) 2016 (361 days post-procedure), the follow-up clinical assessment revealed a study leg rutherford classification of 0.The study lesion status was patent and the patient was still taking aspirin.On (b)(6) 2017 (619 days post-procedure), an occlusion/restenosis was observed in the study vessel.The signs were persistent claudication and angiography evidence with percentage diameter stenosis of 100 %.No treatment was provided.This was considered definitely related to the device but also the pre-existing condition of a restenotic sfa was noted as a contributor.On (b)(6) 2017 (718 days post-procedure), the follow-up clinical assessment revealed that an occlusion was still present in the treated vessel.The study leg rutherford classification was 0.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8137602
• MDR Text Key: 130330559
• Report Number: 3001845648-2018-00565
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513447
• UDI-Public: (01)10827002513447(17)170722(10)C1143516
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2018

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 Expiration Date: 07/22/2017
• Device Catalogue Number: ZIV6-35-125-6.0-100-PTX
• Device Lot Number: C1143516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• 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: 62 YR
• Patient Weight: 74