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

Model Number	ZFEN-P-2-30-124-R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a procedure where a zenith fenestrated aaa endovascular graft proximal body, g32543, zenith fenestrated aaa endovascular graft distal bifurcated body, g32551, zenith flex with spiral-z technology aaa endovascular graft iliac leg, g55226, and zenith flex with spiral-z technology aaa endovascular graft iliac leg, g55243, were used.At completion of the procedure there appears to be numerous type 3 endoleaks in the zfen-p and the zsle limbs.The medical director performed a preliminary review of the imaging provided and confirmed the presence of a type iiia endoleak that appears to be small enough to settle spontaneously once the heparin is reversed or wear off.

• 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 4113 ; AU 4113
• MDR Report Key: 24116299
• Report Number: 3005580113-2026-00008
• Device Sequence Number: 9515630
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)281117(10)AC1199966
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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 Model Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1199966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2026
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026