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 Occlusion Within Device (1423)

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

Event Date 07/09/2013

Event Type  Injury  

Event Description

On (b)(6) 2012, the complaint ptx stent was placed in right upper sfa, (b)(6) 2013 although no symptoms were observed to the patient, restenosis (50-99%) in the lesion where the complaint stent was implanted was confirmed, (b)(6) 2013 pta was performed against the restenosis and the condition of the patient recovered.No further adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

(b)(4).The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the info provided, a document based investigation was carried out.Although requested images relating to this event have not been received.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 this device.The complaint is confirmed based on customer testimony.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.Due to lack of images no other comments can be provided at this time.Quality engineering will continue to monitor complaints for 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 specialist ; 61334440
• MDR Report Key: 4283394
• MDR Text Key: 5299656
• Report Number: 3001845648-2014-00248
• 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: 10/27/2014

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: 05/12/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C777372
• Other Device ID Number: (01)10827002513454(17)140512(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: 07/09/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/19/2014
• 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: 74 YR