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

Catalog Number ZIV6-35-125-6-100-PTX

Device Problem Restricted Flow rate (1248)

Patient Problems Amputation (1702); Gangrene (1873)

Event Date 10/24/2014

Event Type  Injury  

Event Description

On the (b)(6) 2014 the pt underwent an aortogram on the right leg and the physician implanted two zilver ptx stents (one 6x 100 and one 6x80).On the (b)(6) 2014 there was no blood flow down the leg and it appeared the stents had shut down not allowing the blood to flow.Due to some gangrene setting in the physician amputated the leg below the knee on the (b)(6) 2014.On the (b)(6) 2014 the pt had covered stents placed inside the zilver ptx stents to allow the blood flow to the distal end of the leg stump.The info received indicated the pt is well.This report relates to the ziv6-35-125-6-100-ptx device.Reference also relates mdr report 3001845648-2014-00312.

Manufacturer Narrative

(b)(4).The device involved in this complaint remains implanted in the pt therefore will not be returned to cook ireland for eval.With the info provided a document based investigation was carried out.Angiography images have been requested but images are not available to be provided.As the device has not been received the cause of this complaint could not be conclusively determined.From the info provided, the stent placed was occluded approx 1 month after placement.It is possible that this occlusion could be related to thrombotic occlusion, however as images and additional info are not available to be provided, this cannot be conclusively determined.Thrombosis is a known potential adverse effect as per (b)(4).The below list indicates potential risk factors that can generally contribute to the thrombosis event: pt factors, diabetes, especially if poorly controlled, cancer, smoking,.From the info provided, plavix was not being taken at times per prescribed instructions.The customer complaint could be confirmed based on customer testimony.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the mfg records for zilver ptx and zilver ptx drug eluting stent could not be performed as the lot number was not provided.From the info provided, the pt had covered stent placed inside the zilver stent to get the blood flow to the distal end of the leg stump after the amputation.The pt is doing well.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr specialist ; 61334440
• MDR Report Key: 4332200
• MDR Text Key: 5142394
• Report Number: 3001845648-2014-00311
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6-100-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: 10/24/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Age: 64 YR
• Patient Weight: 106