MAUDE Adverse Event Report: COOK, INC. ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TFFB-36-95-ZT

Device Problem Leak/Splash (1354)

Patient Problem Surgical procedure, additional (2564)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

An (b)(6) pt with a pre-existing aaa is taken to surgery for a standard evar procedure.When the final angio was placed, a leakage was noticed in the middle part of the main body.They could see that the leak came from the graft.It looked like a type 4 endoleak from the fabric.Possibly a leak from one of the sutures on one of the middle stent segments.A "cuff" in form of a zenith flex aaa endovascular graft extension was placed inside the main body over the leaking area and caused the leakage to stop.A final angio was done that demonstrated no more leakage.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4669228
• MDR Text Key: 16562158
• Report Number: 1820334-2015-00165
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: TFFB-36-95-ZT
• Device Lot Number: 5468712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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 Age: 81 YR