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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stenosis (2263); Claudication (2550)

Event Date 04/27/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-7.0-120-ptx stent of lot number c779499 was implanted in the patient and is therefore not available for evaluation.With the information provided a document based investigation was carried out.It was confirmed that images would not be available to support the complaint investigation.According to complaint information provided, the patient had pre-existing conditions including coronary artery disease, hypercholesterolemia and was a previous smoker.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however a definitive cause of this event cannot be determined.Due to lack of imaging no other comments can be made.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It may be noted that restenosis of the stented artery is a known potential adverse event associated with placement of this device.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.According to information provided pta was performed and the patient recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012: ziv6-35-125-7.0-120-ptx x 1 + ziv6-35-125-7.0-120-ptx x 1 were placed in the left sfa of the patient.On (b)(6) 2014: restenosis in the lesion was confirmed.(the rpn or lot number of the stenosed device(s) cannot be determined.) on (b)(6) 2014: pta was performed.The patient recovered on each day.On (b)(6) 2015: restenosis in the lesion was confirmed."worsen claudication" was observed.(the rpn or lot number of the stenosed device(s) cannot be determined.) on (b)(6) 2015: pta was performed.The patient recovered.On (b)(6) 2015: restenosis in the lesion was confirmed.(the rpn or lot number of the stenosed device(s) cannot be determined.) on (b)(6) 2015: pta was performed.The patient recovered.As two zilver ptx devices are reported to be involved in this event a report has been submitted for each suspect device.The complaint information received confirmed three separate events of intervention (pta) as a result of restenosis with these devices.A separate report has been submitted for each recorded event also.Reference also related reports 3001845648-2016-00016, 3001845648-2016-00017, 3001845648-2016-00018, 3001845648-2016-00019 & 3001845648-2016-00020.

• 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 Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5382377
• MDR Text Key: 36468215
• Report Number: 3001845648-2016-00021
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/25/2015
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2012
• 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