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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient of undisclosed gender and age underwent an unspecified procedure in which the zenith bifurcated body graft was used.It was further stated there was a possible tear in the bifurcation.The following further information was provided regarding the procedure.The proximal graft was placed in accordance to ifu, ballooning of proximal graft with a 32 coda balloon, bilateral renal stenting with gore viabahn vbx stents, ballooning of renal stents with a mustang 10x2 balloon, placement of distal graft in accordance to ifu, placement of zsle 16 limb in patient¿s left iliac, placement of zsle 16 in patient¿s right iliac, ballooning of proximal and distal body using a 32 coda balloon, ballooning of proximal overlap of zsles with distal body and iliacs using a 32 coda balloon, placement of 26 esbe at proximal and distal body overlap when endoleak appeared on angiogram, re-balloon of proximal and distal body overlap where esbe was placed.

• 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; eight mile plains; brisbane 4113 ; AU 4113
• MDR Report Key: 23787970
• Report Number: 3005580113-2025-00077
• Device Sequence Number: 10477175
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)280403(10)AC1182048
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/01/2025
• Report Date (Section F): 12/12/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1182048
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2025
• Date Report to Manufacturer: 12/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 04/03/2025
• 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: 12/12/2025