MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Insufficient Information (3190)

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

Event Date 04/28/2014

Event Type  Injury  

Event Description

On (b)(6) 2012, three ptx stents were placed in right sfa; 2 x ziv6-35-125-6.0-120-ptx and 1 x ziv6-35-125-6.0-40-ptx.On (b)(6) 2014, restenosis (50-99%) in the lesion where the complaint stents were implanted and confirmed, which extended throughout all three stents.Worsen claudication and worsen rutherford were observed to the pt.Pta was performed against the restenosis on (b)(6) 2014 and the pt recovered.This report relates to one of the ziv6-35-125-6.0-120-ptx devices.Ref also related mdr reports 3001845648-2014-00266 and 3001845648-2014-00267 for the other two devices.

Manufacturer Narrative

Pma/510(k) #: p100022/s001.(b)(4).This incident meets the reporting criteria of a fda mdr report based on intervention carried out (pta was performed) as a result of the occurrence of restenosis while a zilver ptx stent was indwelling.The zilver ptx device involved in this complaint was implanted in the pt; therefore, is not available for eval.With the info provided, a document based investigation was carried out.Images were not available to support the complaint investigation.It may be noted that re-stenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (eg during pta and/or stenting).Vessel injury provokes an inflammatory response that leads (or amplifies) to the restenosis process.Restenosis of the stented artery is a known potential adverse event associated with the placement of this device.A review of the mfg records revealed no discrepancies related to this complaint issue.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.The complaint is confirmed based on customer testimony.Quality engineering assessed the complaint and the risk has been determined to be low.Quality engineering will continue to monitor complaint of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: subead burke, unk ; 3536133444
• MDR Report Key: 4309117
• MDR Text Key: 5197252
• Report Number: 3001845648-2014-00265
• 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: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C780262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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: 82 YR