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

Model Number	G60342
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The part of the beacon tip catheter built into the delivery system was left in the external iliac when it was deployed.The portion of the device was not retrieved.They finished the procedure was finished regardless of the portion left behind.

• Brand Name: ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION,
• 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: 24506626
• Report Number: 3005580113-2026-00017
• Device Sequence Number: 21436384
• Product Code: MIH
• UDI-Device Identifier: 10827002603421
• UDI-Public: (01)10827002603421(17)280105(10)A1203322
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2026
• Report Date (Section F): 03/04/2026

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: G60342
• Device Catalogue Number: ZBIS-10-61-41-US
• Device Lot Number: A1203322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• 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 Age: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/04/2026