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

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

Device Problem Occlusion Within Device (1423)

Patient Problems Amputation (1702); Thrombosis (2100); Surgical procedure, additional (2564)

Event Date 04/18/2015

Event Type  Injury  

Event Description

The patient had an occluded left sfa.The physician used an outback catheter and then placed six zilver ptx stents.Immediately after stent placement, subsequent imaging exposed thrombosis of the stented area with distal embolization of tibial vessels present.They were unsuccessful at removing the thrombus with mechanical devices.The patient subsequently had their lower leg amputated.As per the above description of event received, six devices are involved in this incident.Five additional reports will be submitted in relation to the other devices reported- report reference numbers: 3001845648-2015-00110, 3001845648-2015-00111, 3001845648-2015-00112, 3001845648-2015-00113 and 3001845648-2015-00114.

Manufacturer Narrative

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

• 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, senior specialist ; 61334440
• MDR Report Key: 4787547
• MDR Text Key: 5879853
• Report Number: 3001845648-2015-00109
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2016
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C1098063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR