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

Catalog Number TFFB-28-82-ZT

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Death (1802)

Event Date 10/21/2014

Event Type  Death  

Event Description

An emergency stent graft placement was conducted for ruptured aaa on a (b)(6) female patient with osteoarthritis and (b)(6), on (b)(6) 2014.There was tortuosity in the proximal neck.The patient was not suitable for the procedure due to calcification and tortuosity in the proximal neck.Zenith flex devices were placed with following the normal procedure.Angiography after touch-up ballooning with coda confirmed type is endoleak, (1820334-2014-00583).Since the main body was placed in the pocket of proximal tortuosity which was lower than just beneath the renal arteries, a zenith main body extension was additionally placed.When touch-up ballooning with coda was performed in the proximal neck, acute reduction of blood pressure was observed.Since it was highly likely that dissection toward renal arteries or rupture occurred, bare stents wer placed in the renal arteries with chimney technique and another main body extension was additionally placed to extend the covered area in the proximal side.Although blood pressure was maintained when the aorta was blocked with a balloon, it dropped when the balloon was deflated.This situation continue and finally the patient had cardiac arrest at 11:40 (am/pm unknown), so external pacemaker was used.However, the patient was confirmed dead at 12:20 (am/pm unknown) on (b)(6) 2014.

Manufacturer Narrative

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

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4279736
• MDR Text Key: 5006253
• Report Number: 1820334-2014-00582
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: TFFB-28-82-ZT
• Device Lot Number: 4801909X
• Other Device ID Number: 011082700248417417160201104801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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 Outcome(s): Death
• Patient Age: 79 YR