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	G60340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event per the complaint email: dr hosp unc ide preloaded fen prox case with zbis rt iliac.Product: zbis-10-45-41-us lot a1201336 long story but during the advancing the zbis the operator thought that the dilator hit the rt renal and sma branch stents.At the end of procedure, they assess the status of the branches.They confirmed the sma was occluded.Several attempts were made and eventually gained access and repaired the sma stent.Patient was completed without any complications.Patient outcome: the procedure was completed without complications.

• 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 ; AU
• MDR Report Key: 24512429
• Report Number: 3005580113-2026-00016
• Device Sequence Number: 9942954
• Product Code: MIH
• UDI-Device Identifier: 10827002603407
• UDI-Public: (01)10827002603407(17)271204(10)A1201336
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2026
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: G60340
• Device Catalogue Number: ZBIS-10-45-41-US
• Device Lot Number: A1201336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/16/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2026
• 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): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/04/2026