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 08/05/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001 niu.The ziv6-35-125-6.0-120-ptx stent of lot number c778923 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It is known that the patient had the following pre-existing conditions: hypertension & smoking.It was stated by the originator that there is no imaging available for review.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 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.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 can be therefore stated that it is 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.It may be noted that as per the packaging insert, restenosis of the stented artery is a known potential adverse event associated with the placement of this device.As per the packaging insert, worsened claudication is also a potential adverse event related to 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 c778923.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 c778923.Pta was performed was required as a result of this occurrence.The patient's condition has been recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012: ziv6-35-125-6.0-120-ptx (c778923) was placed in the patient's right upper sfa.On (b)(6) 2013: restenosis (50-99%) in the lesion was confirmed.Worsen claudication was observed on the patient.On (b)(6) 2013: pta was performed.The patient's condition has been recovered.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6559641
• MDR Text Key: 74894400
• Report Number: 3001845648-2017-00168
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140426(10)C778923
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• 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: 05/11/2017
• Event Location: Hospital
• Date Manufacturer Received: 04/13/2017
• Date Device Manufactured: 06/21/2012
• 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: 81 YR