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 Problems Stenosis (2263); Claudication (2550)

Event Date 04/17/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx stent of lot number c777372 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.Available information stated that the patient had pre-existing conditions including coronary artery disease, hypertension, hypercholesterolemia and was a previous smoker.According to complaint information provided, worsen claudication was observed on the patient.It can be noted that 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 limited information and 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 another zilver ptx stent was placed and the patient had a favourable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012 a ziv6-35-125-6.0-120-ptx device (lot# c778923), a ziv6-35-125-6.0-120-ptx device (lot# c777372) and a ziv6-35-125-6.0-40-ptx device (lot# c772688) were placed in the left sfa.On (b)(6) 2015 restenosis (50-99%) was confirmed at +/-5mm of the stented lesion.Worsen intermittent claudication was observed on the patient.On (b)(6) 2015 another zilver ptx device was placed.As per the above description of event received, three devices are involved in this incident.This report addresses the investigation of 1 x ziv6-35-125-6.0-100-ptx device of lot# c777372).Additional reports will be submitted in relation to the other two devices reported- report reference numbers: 3001845648-2015-00203 and 3001845648-2015-00205.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx stent of lot number c777372 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation and the following comments were provided by the independent reviewer: ¿findings: secondary intervention angiography is provided with the complaint report.The stents spanned the entire left sfa with an aggregate stented length of 24cm.Stenosis consistent with neointimal hyperplasia involved all three stents.It was moderate, 50% in the middle of the 40mm long proximal stent, in the proximal portion of the middle stent, and in the proximal and mid portion of the distal stent.A 5mm long 80% stenosis (1.2mm/6mm) was present in the distal aspect of the mid stent.The 80% significantly improved to 50% with angioplasty although the distal stent stenosis did not improve.After it was angioplastied, a new stent placed from the mid stent through the distal stent eliminated any residual stenosis.Two vessel runoff into the foot was provided by the anterior tibial and peroneal arteries.No inflow stenosis from the mid external iliac artery through the common femoral artery was present.Impression: in-stent stenosis consistent with neointimal hyperplasia was confirmed in all three stents.It was severe in the mid stent.The stenosis resolved after angioplasty and stenting.Significant findings relative to the patient¿s anatomy were not observed.Significant findings relative to the disease state were not observed.Significant findings relative to the use of the device were observed.The stented length was extensive at 24cm.Significant findings relative to the design or performance of the device were observed.The stents developed neointimal hyperplasia.¿ the customer complaint can be confirmed as the stents developed neointimal hyperplasia.According to the imaging review, in-stent stenosis consistent with neointimal hyperplasia developed in all three stents.The stenosis was resolved after angioplasty and stenting.Available information stated that the patient had pre-existing conditions including coronary artery disease, hypertension, hypercholesterolemia and a history of tobacco use.Worsen claudication was also observed on the patient.It can be noted that 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 the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.Based on the above, 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.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 another zilver ptx stent was placed and the patient had a favourable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the receipt and review of images relating to this event.Initial description submitted as follows: on (b)(6) 2012 a ziv6-35-125-6.0-120-ptx device (lot# c778923), a ziv6-35-125-6.0-120-ptx device (lot# c777372) and a ziv6-35-125-6.0-40-ptx device (lot# c772688) were placed in the left sfa.On (b)(6) 2015 restenosis (50-99%) was confirmed at +/-5mm of the stented lesion.Worsen intermittent claudication was observed on the patient.On (b)(6) 2015 another zilver ptx device was placed.As per the above description of event received, three devices are involved in this incident.This report addresses the investigation of 1 x ziv6-35-125-6.0-100-ptx device of lot# c777372.Additional reports will be submitted in relation to the other two devices reported- report reference numbers: 3001845648-2015-00203 and 3001845648-2015-00205.

• 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: 5167738
• MDR Text Key: 28907642
• Report Number: 3001845648-2015-00204
• 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
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• 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: 04/17/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2012
• 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: 67 YR