MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Surgical procedure (2357); Claudication (2550)

Event Date 08/26/2014

Event Type  Injury  

Event Description

Patient is participating in a (b)(4) study (b)(4) and had a zilver ptx stent placed in their left proximal sfa.The patient went in for medical evaluation on (b)(6) 2014 due to worsening claudication/rest pain.An ultrasound was performed at this visit and showed an occlusion proximal, within and distal to the study lesion.On (b)(6) 2014, an angiogram was performed and the physician was unable to cross the lesion and consequently there was no treatment of the occlusion.The patient then became a candidate for bypass surgery.The comment on the ae form states: "all stents occluded per angio and duplex - no intervention performed possible leg bypass in future." the patient presented for their 12 month follow-up clinical assessment, x-ray and duplex ultrasound on (b)(6) 2014.The duplex ultrasound findings show an occlusion proximal, within & distal to the study lesion.The x-ray of the study stents and nonstudy stent were negative for evidence of fracture.The patient remains a candidate for bypass surgery.The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).Incident requires fda mdr report based on the surgical intervention planned (planned bypass surgery) in response to the occlusion within the lesion where a zilver ptx stent was indwelling.The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; 61334440
• MDR Report Key: 4370142
• MDR Text Key: 5234730
• Report Number: 3001845648-2014-00340
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

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: 12/11/2013
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C936025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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: 63 YR