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

Model Number	G32562
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter: during the original implant on (b)(6) 2025, an endoleak was observed, but its cause had not been confirmed at the time.A follow-up ct scan on (b)(6) 2025, showed that the aneurysm had grown by 0.5 cm.Another ct scan on (b)(6) 2025, revealed an additional 1.0 cm of growth.On (b)(6) 2025, the patient underwent an angiogram and bilateral limb component ballooning, but the procedure did not resolve the aneurysm, and no further interventions were performed at that time.A subsequent ct scan on (b)(6) 2026, showed an additional 0.5 cm of growth.On (b)(6) 2026, the patient had an intervention in which a gore excluder was implanted to resolve the issue.During the implant procedure, the device ifu was followed, and the device functioned as expected while following the ifu.The endoleak was discovered on the final angiogram during the deployment procedure.There were no adverse events, but the patient was at risk for pending rupture.The patient outcome was a successful re-intervention.No part of the procedure was performed off-label or outside the patient selection criteria.There were no difficulties experienced during deployment.The patient¿s anatomy was a little tortuous, but not problematic.The physician believes a fabric tear at the crotch of the graft caused the issue.The shape of the neck anatomy was angulated and reverse funnel.The graft was ballooned at all seal zones and overlap sites, and extra ballooning was performed as a pre- or post-implantation adjunctive procedure.The graft was able to be deployed in the target zone.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
• 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: 24335292
• Report Number: 3005580113-2026-00013
• Device Sequence Number: 15895908
• Product Code: MIH
• UDI-Device Identifier: 10827002325620
• UDI-Public: (01)10827002325620(17)280207(10)AC1177876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2026
• Report Date (Section F): 02/13/2026

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: G32562
• Device Catalogue Number: ZFEN-D-16-45-76-C
• Device Lot Number: AC1177876
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2026
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/13/2026