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

Catalog Number ZIV6-35-125-7.0-40-PTX

Device Problem Insufficient Information (3190)

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

Event Date 09/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2012 two zilver ptx stents, ziv6-35-125-6.0-60-ptx and ziv6-35-125-7.0-40-ptx were placed in the left sfa.On (b)(6) 2014 stenosis in the two stents was confirmed.Worsen claudication was observed.On (b)(6) 2014 poba was performed.The patient had a favourable outcome and was discharged from the hospital.This report relates to the ziv6-35-125-7.0-40-ptx device.Reference also related report 3001845648-2014-00274 for the ziv6-35-125-6.0-60-ptx device.

Manufacturer Narrative

Pma/510(k)#: p100022/s001.(b)(4).This incident meets the reporting criteria of an fda mdr report based on the surgical intervention carried out as a result of the occurrence of restenosis while a zilver ptx stent was indwelling in the lesion.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.It maybe 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 to (or amplifies) the restenosis process.Additional comment from the physician is as follows: "it was usual restenosis." restenosis, worsened claudication of the stented artery are known potential adverse events associated with the placement of this device.A review of the manufacturing 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.Since there are no images available for review, there is no evidence to suggest that re-stenosis did not occur.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 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 burke, unk ; 3536133444
• MDR Report Key: 4314881
• MDR Text Key: 5246615
• Report Number: 3001845648-2014-00275
• 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: 10/21/2013
• Device Catalogue Number: ZIV6-35-125-7.0-40-PTX
• Device Lot Number: C772910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/22/2014
• 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: 05/31/2012
• 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: 72 YR