MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZFEN-P-2-26-109

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2018

Event Type  Injury  

Event Description

The physician reported difficulty cannulating the right renal artery due to a misaligned fenestration (¿right kidney opening is a little high, difficult to cannulate¿); however, a right renal stent was placed as planned.

Manufacturer Narrative

The device was not returned for evaluation.No medical imaging was provided for this complaint.Work order (b)(4) was reviewed and appears complete and correct.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per the form signed by the physician.The device ifu states: fenestrated grafts are made to a customised design to a specification requested by the responsible physician, and are tailored to a specific patient¿s anatomy.Inaccurate placement and/or incomplete sealing of the zenith fenestrated aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.Unless medically indicated, do not deploy the zenith fenestrated aaa endovascular graft in a location that will occlude arteries necessary to supply blood flow to organs or extremities.Do not cover significant renal or mesenteric arteries (exception is the inferior mesenteric artery only if the superior mesenteric artery and the anastomosis of riolan are patent and functioning correctly) with the endoprosthesis.Vessel occlusion may occur.Clinical studies have identified that with use of the zenith fenestrated aaa endovascular graft there is a risk of renal impairment/loss (which could lead to a need for dialysis).Based on the information received it is difficult to determine an exact root cause.It is possible the following factors may have contributed to the complaint: procedural complications due to patient related factors.Graft positioning during deployment.

Event Description

The physician reported difficulty cannulating the right renal artery due to a misaligned fenestration (¿right kidney opening is a little high, difficult to cannulate¿); however, a right renal stent was placed as planned.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 9107486
• MDR Text Key: 162975226
• Report Number: 9680654-2019-00035
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381534
• UDI-Public: (01)10827002381534(17)211016(10)AC1025530
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: ZFEN-P-2-26-109
• Device Lot Number: AC1025530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other