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

Catalog Number ZIV6-35-125-6.0-40-PTX

Device Problem Occlusion Within Device (1423)

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

Event Date 07/14/2014

Event Type  Injury  

Event Description

On (b)(6) 2012, two zilver ptx stents were placed in the right sfa.On (b)(6) 2014, worsened intermittent claudication occurred to the pt.On (b)(6) 2014, the occlusion was confirmed where the zilver ptx stents were placed.Pta and another mfr's stent placement was performed.There have been no further adverse effects tot he pt reported as occurring.Reference also related report mdr re f# 3001845648-2014-00339.

Manufacturer Narrative

(b)(4).The info received relating to this event is currently being investigated.A follow-up mdr will be submitted with the investigation conclusions.

• 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 ; EI ; 61334440
• MDR Report Key: 4370143
• MDR Text Key: 18923105
• Report Number: 3001845648-2014-00338
• 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: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2014
• Device Catalogue Number: ZIV6-35-125-6.0-40-PTX
• Device Lot Number: C772688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2012
• 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: 66 YR