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

Catalog Number TFFB-24-96-ZT

Device Problem Rupture, cause unknown (1548)

Patient Problem Rupture (2208)

Event Date 01/10/2014

Event Type  Injury  

Event Description

A (b)(6) old, female patient was undergoing an endovascular aaa procedure on (b)(6) 2014.There was some calcification throughout the aorta.The main body endovascular stent graft was placed and a zsle iliac leg was placed (only 1 limb was deployed as the physician believed they were able to obtain an adequate seal on the hypogastric side without the use of a second modular limb).The placement went well.After the final ballooning with a coda balloon, the anesthesiologist indicated the patient's blood pressure was dropping, as well as heart rate.The aorta had ruptured and the patient was immediately converted to an open procedure to control the bleeding.The physician explanted the graft and repaired surgically.It was indicated a hole was noted on the back side of the aorta, believed to have been caused by a piece of calcification.The patient was stable after the surgical procedure and is doing fine.Update (b)(4) 2014 - information received that the patient is doing fine.

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 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3608555
• MDR Text Key: 4066322
• Report Number: 1820334-2014-00047
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: TFFB-24-96-ZT
• Device Lot Number: 4495022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2013
• 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
• Treatment: CODA-10.0-35-100-32
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR