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 Occlusion (1984); Claudication (2550); Surgical procedure, additional (2564)

Event Date 07/28/2014

Event Type  Injury  

Event Description

On (b)(6) 2012 a ziv6-35-125-6.0-40-ptx (ref mdr report# 3001845648-2014-00269) and ziv6-35-125-6.0-120-ptx (this report) were implanted in the left sfa.On (b)(6) 2014 the patient showed worsened claudication.The occlusion was observed in the lesion where the zilver ptx stents were implanted.Pta and thrombectomy were performed.There have been no further adverse effects to the patient reported as occurring as a result of this incident.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).The zilver ptx device involved in this complaint is as follows: ziv6-35-125-6.0-120ptx of lot number c775581.This device contains the zilver ptx drug eluting stent.The zilver ptx stent in question was implanted in the patient and was therefore not available for evaluation.From the information provided a document based investigation was carried out.Although requested images relating to this event were not provided.The following comment was provided by the physician in relation to this complaint: "the occlusion might happen due to a severe lesion.We performed thrombectomy but it was not thrombosis".The following additional information was also provided in relation to this complaint; the target site was severely calcified and worsened claudication was observed.Further information received in relation to this complaint states that the occlusion observed is related to restenosis.It may be noted that 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 (or amplifies) to the restenosis process.A review of the relevant manufacturing records for this zilver ptx device revealed no discrepancies which could have contributed to this complaint issue.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Worsen claudication and restenosis of the stented artery are noted as potential adverse events associated with the placement of this device.Due to the lack of images it is not possible to conclusively determine the root cause for this complaint, the complaint is confirmed based on customer testimony.As per the information received there have been no further adverse effects to the patient reported as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, senior specialist ; 61334440
• MDR Report Key: 4314860
• MDR Text Key: 5246610
• Report Number: 3001845648-2014-00270
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2014

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 Expiration Date: 04/30/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C775581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/28/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR