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

Catalog Number ZIV6-35-125-6.0-80-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550); Surgical procedure, additional (2564)

Event Date 11/13/2014

Event Type  Injury  

Event Description

On (b)(6) 2013, pta with stenting of the left sfa of the patient with two zilver ptx devices was performed.The patient stayed overnight at the hosp and the next day the stents were occluded.The patient also had back problems and it was not clear from where the pains came from.Claudication also remained.On (b)(6) 2014, the physician carried out pta again in response to the occlusion of the stents.The physician discovered one zilver ptx stent was fractured and did a instent-stenting with a supera stent.The physician has reported a favourable outcome for the patient and no further adverse effects to the patient have been reported as occurring.This report specifically relates to the occlusion of one zilver ptx device.The reported occlusion of the second zilver ptx device is addressed within mdr report ref#: 3001845648-2014-00333.The report of the fracture of one zilver ptx stent is addressed within mdr report ref#: 3001845648-2014-00331.

Manufacturer Narrative

The info and images received relating to this event are currently being investigated.A f/u report will be submitted following the completion of the investigation.Pma/510(k)#: p100022 and s001.(b)(4).

• 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,sr. specialist ; 61334440
• MDR Report Key: 4360243
• MDR Text Key: 17589440
• Report Number: 3001845648-2014-00332
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2014
• Device Catalogue Number: ZIV6-35-125-6.0-80-PTX
• Device Lot Number: C813779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2012
• 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: 65 YR