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	G32551
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/01/2022
Type of Reportable Event	Death
Event or Problem Description
Thrombosis of the device.(believed to be most likely due to hypovolemia.) patient death, possible mi or cardiac arrest.The physician believes patient death was not caused by the implanted device.
Event or Problem Description
Thrombosis of the device.(believed to be most likely due to hypovolemia.) patient death, possible mi or cardiac arrest.The physician believes patient death was not caused by the implanted device.
Additional Manufacturer Narrative
No part of the device was returned for evaluation.No images were available for evaluation.A review of device history record for work order number (b)(4) was reviewed and appears complete and correct.The device was manufactured to specification there was no fault or failure and did not reveal any discrepancies that could have contributed to the adverse event.The medical director reviewed the information supplied and stated - "there is very little information in the report for this adverse event.Given that the event apparently occurred at home, and that dr (b)(6) believes that the thrombosis was secondary to hypovolemia and/or cardiac arrest, rather than the cause of the death, i don¿t see this as being a fault or failure of the zfen device in any way.We have no additional information that would change that assumption¿.The instruction for use (ifu) supplied with the device states: warnings and precautions implant procedure systemic anticoagulation should be used during the implantation procedure based on hospital and physician preferred protocol.If heparin is contraindicated, an alternative anticoagulant should be considered.Inaccurate placement and/or incomplete sealing of the zenith fenestrated aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.It is recommended that all vessels accommodated by a small fenestration be stented in order to secure positive alignment of the graft fenestration with the vessel origin.5.Adverse events potential adverse events that may occur and/or require intervention include, but are not limited to: ¿ arterial or venous thrombosis and/or pseudoaneurysm ¿ death ¿ occlusion of device or native vessel ¿ renal complications and subsequent attendant problems (e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure).Based on the information provided, the root cause could not be determined.However, the possible root causes could be - twisting of implant within the delivery system - kinking/ collapse/ excessive prolapse of implant/ folding of implant material between stents - collapse of implant due to stent fracture/detachment - rough surface prone to thrombus formation - inadequate medication of patient with anti-coagulants - inadequate spacing between stents - patient's factors.

• 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): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 15912599
• Report Number: 9680654-2022-00023
• Device Sequence Number: 14552149
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)250926(10)AC1118450
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2025
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1118450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/04/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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: 77 YR
• Patient Sex: Female