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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problem Claudication (2550)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx stent of lot number c780031 was implanted in the patient therefore is 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.Further information was provided detailing procedure and anatomy information.Additional information stated that the physician had previous experience with zilver ptx and there were no difficulties in deploying the stent.The information also stated that no factors regarding patient anatomy could have contributed to the event.Available information stated that the patient had pre-existing conditions including type i diabetes and hypercholesterolemia.According to complaint information provided, worsened claudication was observed on the patient.It can be noted that this symptom (worsen claudication) indicates progression of peripheral artery disease and can also be associated with the restenosis process.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 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.As no imaging was available to support the complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that worsened claudication and restenosis of the stented artery are known potential adverse events 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 (poba) and thrombus aspiration were 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: two zilver ptx stents, ziv6-35-125-6.0-120-ptx/ c780031 + ziv6-35-125-6.0-60-ptx / c781079 were placed in the right distal sfa.On (b)(6) 2015: 100% restenosis was confirmed at +/-5mm of zilver stents.Worsen claudication was observed.On (b)(6) 2015: pta (poba) and thrombus aspiration were performed.The patient recovered.As per the above description of event received, two devices are involved in this incident.This report addresses the investigation of 1 x ziv6-35-125-6.0-100-ptx device of lot# c780031.An additional report will be submitted in relation to the other device reported- report reference number: 3001845648-2015-00182.

• 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 ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5099656
• MDR Text Key: 26593167
• Report Number: 3001845648-2015-00181
• 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: Health Professional
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-120-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: 08/14/2015
• Event Location: Hospital
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2012
• 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
• Patient Age: 78 YR