MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZBIS-12-61-41-US; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G60345
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per complaint email: "good afternoon.I am once again reporting more fabric leaks from (redacted) endografts.These were picked up on follow up scan today with the surgeon.The case was originally performed on (redacted).The endoleak is reported to have persisted from the limbs and zbis devices (zenith branch endovascular graft iliac bifurcation, distal dia 12 mm, common iliac segment len 61 mm, external iliac segment len 41 mm)." further information provided stated: the physician attributed the cause to a fabric leak in the device.No pre-existing anatomical conditions (such as vessel calcification or tortuosity) were identified, and no difficulties were encountered during the original deployment.To treat the endoleak, a 16 mm graft was used to reline the affected area, and additional grafts were also implanted as adjunctive measures.No high blood pressure or graft obstruction was observed during the endoleak event.The implanted devices were not available for return.The patient continued to be monitored following the intervention, with no further adverse outcome noted at the time of reporting.

• Brand Name: ZBIS-12-61-41-US
• 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 ; AU
• MDR Report Key: 25349010
• Report Number: 3005580113-2026-00031
• Device Sequence Number: 10326929
• Product Code: MIH
• UDI-Device Identifier: 10827002603452
• UDI-Public: (01)10827002603452(17)270827(10)A1193152
• Combination Product (Y/N): N
• 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): 05/07/2026
• Report Date (Section F): 06/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G60345
• Device Catalogue Number: ZBIS-12-61-41-US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2026
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/01/2026