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

Catalog Number TFFB-26-82-ZT

Device Problem Rupture, cause unknown (1548)

Patient Problems Death (1802); Cardiogenic Shock (2262)

Event Date 12/06/2012

Event Type  Death  

Event Description

A (b)(6) male patient in the (b)(4) study died on (b)(6) 2012 (2 days post=procedure) from a massive mi/cardiogenic shock.The patient was treated on (b)(6) 2012 for an aaa with a maximum aortic aneurysm diameter of 6.1 cm.The proximal neck had a parallel shape with partial plaque/thrombus.The left iliac artery had mild tortuosity, no calcification, and no occlusive disease.The right iliac artery had mild tortuosity, no calcification, and no occlusive disease.The patient rec'd a main-body device, a left iliac leg, a right iliac leg branch device, a left iliac leg extension branch device, and two right iliac leg extensions.There was no difficulty deploying any of the components.A molding balloon was used but no details were provided regarding its use.A covered stent was placed in the right iliac artery prior to the deployment procedure.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, thrombus, or endoleaks.On (b)(6) 2012 (2 days post-procedure), the patient died as a result of a massive mi and cardiogenic shock.Add'l info has been requested but not provided by the reporter.

Manufacturer Narrative

(b)(4).Event evaluation: still 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 47402
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4054518
• MDR Text Key: 4908921
• Report Number: 1820334-2014-00438
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFFB-26-82-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2012
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2014
• 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): Death
• Patient Age: 62 YR