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-2-30-124-R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Multiple Organ Failure (3261)

Event Date 12/19/2023

Event Type  Death  

Event Description

The patient had a zenith fenestrated aaa endovascular graft proximal body implanted.Due to length of procedure & occlusion to renal arteries, patient¿s potassium levels increased.The patient was placed on dialysis which is believed to have caused liver failure.Upon secondary cat scan performed post procedure, it was believed that the superior mesenteric artery (sma) and celiac artery had limited flow.The physician placed stents in each (sma and celiac artery) to improve the blood flow.The cause is undetermined but the physician stated she did not consider it to be device related.Upon follow up conversation with the physician on (b)(6) 2023, the district manager was notified of the additional interventions and that the patient had gone into organ failure and expired.

• 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 ; AS
• MDR Report Key: 18510885
• MDR Text Key: 332867826
• Report Number: 3005580113-2024-00005
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)261116(10)AC1146853
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1146853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2024
• Distributor Facility Aware Date: 12/19/2023
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Date Device Manufactured: 11/16/2023
• 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: 76 YR
• Patient Sex: Female