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 Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k)#: p100022/s001.The incident meets criteria for fda mdr reporting based on the reporting malfunction precedence established for this product family for stent fracture regardless of patient outcome.The ziv6-35-125-6.0-120-ptx stent of lot number c777373 was implanted in the patient, therefore is not available for evaluation.With the information provided a document based investigation was carried out.It was confirmed that no imaging would be available to support the complaint investigation.It is possible that difficult patient anatomy or patient¿s lifestyle could have contributed to this event.However, as no imaging was provided and due to limited information, a definitive root cause cannot be determined and no other comments can be made.As no imaging was available there is no evidence to suggest that stent fracture did not occur.Therefore the complaint is confirmed based on customer testimony.It may be noted that, stent strut fracture is a known potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.No adverse effects to the patient have been reported and no medical/surgical intervention was performed due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012: two zilver stents were placed in the right distal sfa with overlap.On (b)(6) 2015: x-ray confirmed stent fracture (type i) in the proximal site of the stent.(the rpn or lot number of the fractured device(s) cannot be determined.) no further information has been provided.As it is unknown which stent specifically fractured separate reports have been submitted for both suspect devices.Reference also report # 3001845648-2015-00246.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5242230
• MDR Text Key: 31794445
• Report Number: 3001845648-2015-00245
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/23/2015
• 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 Age: 67 YR