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

Model Number	G32541
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/05/2022
Type of Reportable Event	Death
Event or Problem Description
The device would rotate 180 degrees every time it was advanced through the groin.Rotation was eventually corrected and graft deployment was begun.After opening the first two stents, the orientation rotated on the graft.Rotation of the entire system was performed.When the graft was now correctly oriented, the distal end of the graft was opened.Upon, opening the distal end, it was noted that the graft was wrapped around itself (like a candy wrapper).Cannulation of the fenestrations was performed for the arm through the scallop as the physician could not cannulate through the wrapped graft (from below).Therefore, cannulation was done through the arm.Upon removing, the gold trigger wire, the wire snapped.Hemostats were then used to grab the remainder of the wire that snapped from the gold knob.The black trigger wire also snapped at the hub and was unable to be pulled from the device.Therefore, the top cap could not be deployed.The operation was converted to an open procedure.The patient expired in the icu while at the hospital.Note: the patient had an existing endologics graft sitting approx.2 cm's below the patients renals.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 15294596
• Report Number: 3005580113-2022-00096
• Device Sequence Number: 11464574
• Product Code: MIH
• UDI-Device Identifier: 10827002325415
• UDI-Public: (01)10827002325415(17)250617(10)AC1112891
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2022
• Report Date (Section F): 08/25/2022

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 Expiration Date: 06/17/2025
• Device Model Number: G32541
• Device Catalogue Number: ZFEN-P-2-26-124-R
• Device Lot Number: AC1112891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/04/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2022
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/25/2022