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

Catalog Number	ZFEN-D-12-28-76-C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 09 jan 2026, cook medical determined that mdr 3005580113-2025-00073 did not receive fda acknowledgement 3 because a digit was omitted in section f3.The report has been corrected and is being resubmitted under mdr 3005580113-2026-00001.Appropriate corrective and preventive actions have been implemented to prevent recurrence of this error.
Event or Problem Description
A zenith fenestrated aaa endovascular graft distal bifurcated body was implanted on (b)(6) 2025.On an unknown date an angiogram was performed and a type 3 endoleak (tear of fabric of the device) was discovered.The type 3 endoleak was reported to the district manager on (b)(6) 2025.There is no further information at this time.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; brisbane 4113/ ; AU 4113/
• MDR Report Key: 24020890
• Report Number: 3005580113-2026-00001
• Device Sequence Number: 21465616
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)270924(10)AC1168452
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2025
• Report Date (Section F): 11/26/2025

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
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1168452
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/05/2025
• Device Age: 14 MO
• Date Report to Manufacturer: 11/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 09/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/26/2025