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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/19/2023
Type of Reportable Event	Death
Event or Problem Description
Related: (b)(4): due to length of procedure & occlusion to renal arteries, patient¿s potassium increased.Patient was placed on dialysis.This is believed to have caused liver failure.Upon secondary cat scan, post procedure, it was believed that the sma and celiac had limited flow.Physician placed stents in each (sma, celiac) to improve blood flow.The cause is undetermined.Physician stated she felt it was not device related.Upon follow up conversation with the physician on (b)(6) 2023 ¿ [district manager] was notified of the additional interventions and the patient had gone into organ failure and expired.This (b)(4): during review of video received for the related (b)(4); an endoleak was noted by medical director.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: 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: 19053741
• Report Number: 3005580113-2024-00021
• Device Sequence Number: 7104620
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)261116(10)AC1146853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2024
• Report Date (Section F): 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Distributor Facility Aware Date: 03/14/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/05/2024