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 Occlusion (1984); Pain (1994); Claudication (2550)

Event Date 10/23/2014

Event Type  Injury  

Event Description

On (b)(6) 2012 two zilver ptx stents (2x ziv6-35-125-6.0-120-ptx) were placed in the left sfa.On (b)(6) 2014 occlusion due to restenosis in both two stents was confirmed.Worsen rutherford, rest pain and worsen claudication were observed.Pta (poba) was performed though the patient did not recover.This report is in relation to one of the zilver ptx devices.Reference related report 3001845648-2014-00277 for the second device.

Manufacturer Narrative

(b)(4).Incident requires fda mdr report based on the intervention carried out due to the occurrence of occlusion in the lesion where a ptx stent was indwelling.This investigation addresses 1 x ziv6-35-125-6.0-120-ptx of lot c781168.The zilver ptx device involved in this complaint was implanted in the patient and 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.Worsened claudication/rest pain and restenosis of the stented artery are known potential adverse events associated with the placement of this device.Summary of comments provided by the physician and sales rep were as follows: "i reckon that reocclusion was unavoidable due to severe lesion." the complaint is confirmed based on customer testimony.A review of the manufacturing records for ziv6-35-125-.0-120-ptx device of lot # c781168 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.Complaints of this nature will continue to be monitored for 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: sinead quaid, senior regulatory ; limerick ; EI ; 3536133444
• MDR Report Key: 4314959
• MDR Text Key: 5252820
• Report Number: 3001845648-2014-00276
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C781168
• Other Device ID Number: (01)10827002513454(17)140519(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2014
• 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