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 Problem Reocclusion (1985)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.Fda mdr report required based on the surgical interventions [bypass and poba] carried out and the subsequent permanent impairment of the patient [amputation of left lower limb ] following the restenosis of the limb where a zilver ptx stent was indwelling.The ziv6-35-125-6.0-120-ptx stent of lot number c791324 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 images would not be available to support the complaint investigation and no other information could be provided.It can be noted stenosis of the lower limb followed by occlusion of the by-pass, may suggest progressing artery disease.This can be associated with the restenosis process.However, a definitive cause of this event cannot be determined.There is no evidence to suggest that this event did not occur; therefore the complaint is confirmed based on customer testimony.It can be noted that bypass, amputation of foot and restenosis of the stented artery are a known potential adverse event associated with 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 information regarding patient outcome was provided.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(6) 2012 the zilver ptx stent was placed in left sfa of the patient.(b)(6) 2013 by-pass procedure was performed as the left lower limb stenosed 100%.(b)(6) 2014 as by-pass made on (b)(6) 2013 got occluded, poba was performed.(b)(6) 2014 amputation of the lower limb was performed.

• 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: 5235411
• MDR Text Key: 31579429
• Report Number: 3001845648-2015-00244
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 07/01/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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: 78 YR