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

Model Number	G32554
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When they put the device over the patient's abdomen to orient it, they could tell that the contralateral gate was twisted within the sheath.The device was not used.The procedure was successfully completed with another device of the same type.
Additional Manufacturer Narrative
The device was not returned for evaluation although three requests for product return were made.No imaging was received to assist with the investigation.The sales representative advised that the graft might not be available for return.The sales representative stated that the problem was that the device was twisted in the sheath so they had deployed it on the back table after.A review of the device history record (dhr) found that the work order for lot ac1097149 appears complete and correct and the quality control inspection was verified to ensure that the device passed inspection.There were no non-conformances raised or temporary deviations in place at the time of manufacture.There are a number of processes and checks in place at wca to ensure that the graft is loaded in the correct orientation within the delivery system.The investigation concluded that the complaint device was manufactured to specification.The instructions for use supplied with this device was reviewed and it contains appropriate warnings, precautions, and instructions for use of the device.A definitive root cause could not be determined from the investigation.Possible root cause(s) are: inadequate design.Operator error valve twisted during transfer into sheath.A notification of this event was provided to manufacturing.
Event or Problem Description
When they put the device over the patient's abdomen to orient it, they could tell that the contralateral gate was twisted within the sheath.The device was not used.The procedure was successfully completed with another device of the same type.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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 ; AS
• Manufacturer (Section G): COOK AUSTRALIA; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• Manufacturer Contact: majbrit frosig ; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• MDR Report Key: 16493501
• Report Number: 9680654-2023-00021
• Device Sequence Number: 6366748
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)250314(10)AC1097149
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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 Expiration Date: 03/14/2025
• Device Model Number: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1097149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Patient Sex: Unknown