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	G32537
Medical Device Problem Codes	Failure to Advance (2524); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The proximal piece would not advance as it was being advanced over the stiff wire.Therefore, an evar was performed to successfully complete the procedure.When the proximal piece was being prepped and flushed, the technician bent the sheath and in turn it is believed (by both the sales representative and the physician) that the technician bent the inner cannula.The bend was where the graft material starts.At that certain area, they believe that the inner cannula is compressed.
Event or Problem Description
The proximal piece would not advance as it was being advanced over the stiff wire.Therefore, an evar was performed to successfully complete the procedure.When the proximal piece was being prepped and flushed, the technician bent the sheath and in turn it is believed (by both the sales representative and the physician) that the technician bent the inner cannula.The bend was where the graft material starts.At that certain area, they believe that the inner cannula is compressed.
Additional Manufacturer Narrative
The device was returned for evaluation.The complete device was returned and appeared bowed.All components were inspected for non-conformances.The graft was deployed in order to be able to observe the inner cannula.A significant kink at the proximal end of the inner cannula just below the top cap was observed.Additional information was received from the sales representative.A lunderquist wire guide was used.No conduit was used.Dilators were used in the access vessels.A vascular closure device was used prior to access.A review of the device history record found that the work order for lot ac1128279 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.A review of the manufacturing records and/or specifications did not reveal any discrepancies that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.Review of the instructions for use (ifu) supplied with the device found that it contains appropriate instructions for proper placement of the device.There is evidence to suggest that user did not follow the ifu which states: ¿do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith fenestrated aaa endovascular graft.¿ the device was used outside of its validated state therefore the integrity of the device is compromised.It is unknown how the device will function outside of its validated state.A definitive root cause was identified as bending of the inner cannula during preparation.

• 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 ; 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: 16739374
• Report Number: 9680654-2023-00023
• Device Sequence Number: 17858234
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)260217(10)AC1128279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 02/17/2026
• Device Model Number: G32537
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC1128279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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 Age: 68 YR
• Patient Sex: Male