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	G32544
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Type of Reportable Event	Serious Injury
Event or Problem Description
When implanted, the case was challenging and ended up with a type 1a endoleak.The physician explanted the device approximately 3 weeks later.
Additional Manufacturer Narrative
The device was not returned for evaluation.No images were provided for evaluation.The following additional information was requested and received: - was the patient hospitalized or was there prolonged hospitalization due to this occurrence? pt left the hospital after zfen implant.Was readmitted for explant due to endoleak.- did the patient require any additional procedures due to this occurrence? if yes, please describe.Yes, the patient had the zfen explanted & an open aaa was done.- did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Doctor does not believe the device was a fault.Pt anatomy to blame.A review of device history record for work order (b)(4) was reviewed appeared complete and correct.The device was manufactured to specification and did not reveal any discrepancies that could have contributed to the adverse event.The instruction for use (ifu) supplied with the device states: the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up.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."endoleak" is listed as a potential adverse event.Based on the information of the investigation, the most likely root cause is "anatomical characteristics at seal site not suitable for endovascular repair".
Event or Problem Description
When implanted, the case was challenging and ended up with a type 1a endoleak.The physician explanted the device approximately 3 weeks later.

• 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): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane 4113 ; AS 4113
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane 4113 ; AS 4113 ; 738411188
• MDR Report Key: 16360044
• Report Number: 9680654-2023-00015
• Device Sequence Number: 15185163
• Product Code: MIH
• UDI-Device Identifier: 10827002325446
• UDI-Public: (01)10827002325446(17)250915(10)AC1118048
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 09/15/2025
• Device Model Number: G32544
• Device Catalogue Number: ZFEN-P-2-32-124-R
• Device Lot Number: AC1118048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/12/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female