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 Insufficient Information (3190)

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

Event Date 03/26/2014

Event Type  Injury  

Event Description

On (b)(6) 2012: two ziv6-35-125-6.0-120-ptx stents and one ziv6-35-125-7.0-60-ptx stent were placed in the left sfa of the patient.On (b)(6) 2014: "worsened claudication" was observed and diffused restenosis in all three zilver ptx stents was confirmed.Pta was conducted and the patient recovered.No further adverse effects to the patient have been reported as occurring as a result of this specific event.This report relates to one ziv6-35-125-6.0-120-ptx device of lot # c777375.Reference also related mdr reports # 3001845648-2014-00281 and 3001845648-2014-00283.

Manufacturer Narrative

(b)(4).This report relates to one ziv6-35-125-6.0-120-ptx device of lot # c777375.Reference also related mdr reports # 3001845648-2014-00281 and 3001845648-2014-00283.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.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.An additional comment from the physician was as follows: "it was usual restenosis." restenosis, worsen 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; therefore the complaint is confirmed based on customer testimony.Due to the lack of images no other comments can be provided at this time.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 quaid, senior regulatory ; EI ; 61334440
• MDR Report Key: 4314895
• MDR Text Key: 18798607
• Report Number: 3001845648-2014-00282
• 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: 05/04/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C777375
• Other Device ID Number: (01)10827002513454(17)140504(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: 03/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2012
• 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: 76 YR