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 01/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s001.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00565.This investigation deals with the restenosis of the ziv6-35-125-6.0-120-ptx stent of lot number c775728 implanted in the left above-knee popliteal artery.The device was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator in the complaint file that no further information will be provided and no images are available for review.It is known that the patient had the following pre-existing conditions: hypertension, hypercholesterolemia, diabetes (type2), previous smoker (current:not) there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.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 at the time of investigation, a definitive root cause of this event cannot be determined at this time.In addition worsened claudication was also observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.It may be noted that the packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.Worsened claudication is also listed as a potential adverse event in the packaging insert following the 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.Upon review of complaints, this failure mode has occurred previously with the lot number c775728.However based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c775728.Pta was performed against this 100% restenosis and the condition of the patient was improved.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012 - a ziv6-35-125-6.0-120-ptx lot#c775728 was placed in the lower part of left sfa.Also, a ziv6-35-125-6.0-120-ptx lot#c775728 was placed in left above-knee popliteal artery.On (b)(6) 2017 - 100% restenosis in the both of the stented lesions was confirmed.Worsened intermittent claudication was observed on the patient.On (b)(6) 2017 - pta was performed against this 100% restenosis.On (b)(6) 2017 -the patient's condition was improved.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00565.

• 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: 7059249
• MDR Text Key: 93066103
• Report Number: 3001845648-2017-00566
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140427(10)C775728
• Combination Product (y/n): N
• 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: 10/30/2017

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: ZIV6-35-125-6.0-120-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: 11/27/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2017
• Date Device Manufactured: 06/11/2012
• 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
• Patient Age: 77 YR