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

Catalog Number ZIV6-35-125-6.0-60-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: this investigation deals with the restenosis of ziv6-35-125-6.0-60-ptx stent on the (b)(6) 2017.The device was implanted in the patient and is therefore unavailable for investigation.With the information provided a document based investigation was carried out.It is known the patient had the following pre-existing conditions: diabetes (type i) and hypercholesterolemia there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It was determined that there were no images available for review.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (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 as no imaging was available, a definitive root cause of this event cannot be determined at this time.It may be noted that as per the packaging insert worsened claudication & restenosis of the stented artery is a known potential adverse event associated with the placement of this device.Document review: the ziv6-35-125-6.0-60-ptx stent contains zilver ptx drug eluting stent zvsp6-125-6.0-60-is.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.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Pta was conducted as a result of this occurrence.The patient recovered.No other adverse events were reported.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012: two ptx stents were placed in the right sfa.(please refer to product information - notes for product and lot#s.) (b)(4).On (b)(6) 2016: restenosis was confirmed in the lesion.(worsen claudication were observed.) then, pta was performed and the patient recovered.(b)(4).On (b)(6) 2017: restenosis was confirmed in the lesion.(worsen claudication were observed.) then, pta was performed and the patient recovered.(b)(4).On (b)(6) 2017: restenosis was confirmed in the lesion.(worsen claudication were observed.) then, pta was performed and the patient recovered.(b)(4).On (b)(6) 2017: restenosis was confirmed in the lesion.(worsen claudication were observed.) then, pta was performed and the patient recovered.This investigation deals with the restenosis of ziv6-35-125-6.0-60-ptx stent of lot number c781079 on the (b)(6) 2017.

• 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: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6916689
• MDR Text Key: 88828307
• Report Number: 3001845648-2017-00438
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513423
• UDI-Public: (01)10827002513423(17)140518(10)C781079
• 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: 09/06/2017

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: ZIV6-35-125-6.0-60-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: 10/04/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/05/2017
• Date Device Manufactured: 06/27/2012
• 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 Outcome(s): Required Intervention