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	G32536
Medical Device Problem Codes	Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An 81-year-old female patient underwent a zfen for aaa procedure in which the zenith fenestrated aaa endovascular graft proximal body, g32536, was used.The graft was inserted into tortuous anatomy and was rotated (rotating the gray positioner and sheath in unison) to correct position.The graft was unsheathed and candy-wrapping was noticed.The graft was then rotated in the opposite direction to "unwrap".Renal arteries were cannulated and ansel sheaths were advanced into position.When the gold trigger wire was pulled and released, the physician noticed some tension.The black trigger wire was released and pulled with some tension as well.The pin vise was loosened, the top cap was advanced, and the pin vise tightened.The white trigger wire was pulled, and the wire broke off, flush with the trigger mechanism.Advanced trouble shooting techniques were followed to expose the trigger wire.The trigger wire was pulled and extremely tight.Eventually, the wire was removed and the case was completed.Additional information was received: the device was twisted due to the tortuous iliac of the patient.There was some evidence to suggest the graft may have been twisted prior to insertion.The anterior markers were in the 12:00 position, but the horizontal markers were in the 3:00 position.The device positioned on the patient¿s abdomen prior to insertion to confirm that the graft was in the correct orientation.The markers did not form a cross during initial positioning.The thumb screws (rmts) were not aligned at 12 o¿clock, they were aligned around the 1:30 position.Case was successfully completed with no harm to the patient.

• 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 4113 ; AU 4113
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane
• MDR Report Key: 24602063
• Report Number: 9680654-2026-00050
• Device Sequence Number: 21222877
• Product Code: MIH
• UDI-Device Identifier: 10827002325361
• UDI-Public: 10827002325361
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G32536
• Device Catalogue Number: ZFEN-P-2-26-109-R
• Device Lot Number: AC1205060
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CAPA-00080
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female