MAUDE Adverse Event Report: COOK, INC. ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

Catalog Number TFFB-36-113-ZT

Device Problem Rupture, cause unknown (1548)

Patient Problem Rupture (2208)

Event Date 10/12/2014

Event Type  Injury  

Event Description

Info was provided that the graft was implanted (b)(6) 2012 on a male pt.In (b)(6) 2014 this same pt was involved in a traffic accident, no post ct scan.On (b)(6) 2014, the pt had a ruptured aortic aneurysm and was converted to open repair and the graft was explanted.Additional info stated the surgeon was unable to explant the entire stent grafts as they were fixed in place but was able cut out part of the graft.The pt did not experienced any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is still under investigation.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4254655
• MDR Text Key: 5106841
• Report Number: 1820334-2014-00573
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Catalogue Number: TFFB-36-113-ZT
• Device Lot Number: 3238505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2014
• Device Age: 31 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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