MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA 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	Foreign Body In Patient (2687)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter: the icast stent in the internal iliac and the side branch of the zbis was deployed before the through and through catheter was removed.Upon removal of the dilator to the main device, the catheter became trapped behind the stent (another manufacturer) and snapped- between the stent and the side branch.The piece of the catheter is trapped behind the icast stent inside the side branch of the iliac branch device.Further information provided states: on (b)(6) 2026, a cook zenith branch iliac stent (lot a1199911) was implanted in a patient with a pre-existing aorto-iliac aneurysm.The procedure also involved use of another manufacturer's stent, stent-graft, sheath, and a cook indy otw snare.A cook representative was present, and the same day the team noted a device-related nonconformance; however, no adverse events occurred, and no additional procedures were required.

• 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; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• MDR Report Key: 24176416
• Report Number: 3005580113-2026-00006
• Device Sequence Number: 15842232
• Product Code: MIH
• UDI-Device Identifier: 10827002603407
• UDI-Public: (01)10827002603407(17)271117(10)A1199911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2026
• Report Date (Section F): 01/26/2026

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: A1199911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• 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: Female
• Date Report Sent to FDA: 01/26/2026