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 Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550); Surgical procedure, additional (2564)

Event Date 10/09/2014

Event Type  Injury  

Event Description

On (b)(6) 2012, three zilver ptx stents (2 x ziv635-125-6.0-120-ptx and 1 x ziv6-35-125-7.0-120-ptx) stent were placed in right sfa.On (b)(6) 2014, reocclusion of the lesion where the complaint stents were implanted was confirmed.The occlusion, related to restenosis and not thrombosis, extended in all of the stents.Worsen claudication was observed on the patient.Pta (poba with nse balloon), stent placement and aspiration of blood clots were performed against this on the same day and the condition of the patient recovered.This report relates to one ziv6-35-125-6.0-120-ptx device.Reference also related mdr reports 3001845648-2014-00252 and 3001845648-2014-00253 for the other two devices.

Manufacturer Narrative

(b)(4).This incidents meets the reporting criteria of a fda mdr report based on intervention carried out (pta-poba with nse balloon, stent placement and aspiration of blood clots) 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 patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.Images were not available to support the complaint investigation.Prior to distribution, of 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.The complaint is confirmed based on customer testimony.It may be noted that re-stenosis 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.Worsened claudication and restenosis of the stented artery are known potential adverse events associated with the placement of this device.Pta (poba with nse balloon), stent placement and aspiration of blood clots were performed against this on the same day and the condition of the patient recovered.Quality engineering assessed the risk for this complaint it has been determined to be low.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: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND, LTD.; limerick ; UK
• Manufacturer Contact: sinead quaid, sr. specialist ; limerick ; UK ; 61334440
• MDR Report Key: 4283292
• MDR Text Key: 5227602
• Report Number: 3001845648-2014-00251
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100022/S001
• 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

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C793667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• 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: 80 YR