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 Reocclusion (1985); Claudication (2550)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx stent of lot number c778568 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 and no further information will be provided to support the complaint investigation.Available information stated that the patient had pre-existing conditions including: hypertension, hypercholesterolemia and was a smoker.According to complaint information provided, worsened claudication was 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.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 pta and stent placement were preformed against restenosis and the condition of the patient improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx stent of lot number c778568 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 and no further information will be provided to support the complaint investigation.Available information stated that the patient had pre-existing conditions including: hypertension, hypercholesterolemia and was a smoker.According to complaint information provided, worsened claudication was 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.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 pta and stent placement were preformed against restenosis and the condition of the patient improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Two ziv6-35-125-6.0-120-ptx devices were placed in the left sfa of a (b)(6) male patient.On (b)(6) 2015: 50-99% restenosis of the lesion was confirmed.Worsened claudication was observed on the patient.Pta and stent placement (zilver ptx, details unknown) were performed against restenosis and the condition of 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# c778568.An additional report will be submitted in relation to the other device reported- report reference number: 3001845648-2015-00170.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx stent of lot number c776874 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 and no further information will be provided to support the complaint investigation.Available information stated that the patient had pre-existing conditions including: hypertension, hypercholesterolemia diabetes type ii and was history of tobacco use.According to complaint information provided, worsened claudication was 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.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 pta and stent placement were preformed against restenosis and the condition of the patient improved.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 of additional information.Information was received that changed the following details: product lot # product identifier, description, patient¿s information (age, gender, pre existing condition, implant date).Updated description: on (b)(6) 2012: two stents were placed in the left sfa of a (b)(6) female patient.Ziv6-35-125-6.0-120-ptx (c776874), ziv6-35-125-7.0-40-ptx (c772912).On (b)(6) 2015: 50-99% restenosis of the lesion was confirmed.Worsened claudication was observed on the patient.Pta and stent placement (zilver ptx, details unknown) were performed against restenosis and the condition of the patient recovered.Reference also related report # 3001845648-2015-00170.

• 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: 5073637
• MDR Text Key: 25614681
• Report Number: 3001845648-2015-00169
• 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: Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• 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: 08/12/2015
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2012
• 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: 69 YR