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 Adverse Event Without Identified Device or Use Problem (2993)

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; 2x ziv6-35-125-6.0-120-ptx and 1x ziv6-35-125-6.0-40-ptx.On (b)(6) 2014, restenosis (50-99%) in the lesion where the complaint stents were implanted was confirmed, which extended throughout all the three stents.Worsen claudication and worsen rutherford were observed to the patient.Pta was performed against the restenosis on (b)(6) 2014 and the patient recovered.This report relates to one of the ziv6-35-125-6.0-120-ptx devices.Reference also related mdr reports 3001845648-2014-00265 and 3001845648-2014-00267 for the other two devices.

Manufacturer Narrative

Pma/510(k)#: p100022/s001.(b)(4).This incident meets the reported 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.This investigation addresses 1 x ziv6-35-125-6.0-120-ptx of lot c775583.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.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.Restenosis of the stented artery is a known potential adverse event associated with the placement of the device.A review of the manufacturing records for ziv6-35-125-6.0-120-ptx device of lot #c775583 revealed no discrepancies related to this complaint issue.Prior to distribution, all zilver ptx devices are subject to visual inspection and functional checks t ensure device integrity.Since there are no images available for review, there is no evidence to suggest that re-stenosis did not occur; therefore, the complaint is confirmed based on customer testimony.Pta was performed on the patient and the patient recovered.Complaints of this nature will continue to be monitored for 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 burke, unk ; 3536133444
• MDR Report Key: 4314882
• MDR Text Key: 5251174
• Report Number: 3001845648-2014-00266
• 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: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C775583
• 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: 06/11/2012
• 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: 82 YR