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

Catalog Number	ZFEN-P-2-30-124-R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/19/2023
Type of Reportable Event	Death
Event or Problem Description
Related: pr(b)(4): due to length of procedure & occlusion to renal arteries, patient¿s potassium increased.Patient was placed on dialysis.This is believed to have caused liver failure.Upon secondary cat scan, post procedure, it was believed that the sma and celiac had limited flow.Physician placed stents in each (sma, celiac) to improve blood flow.The cause is undetermined.Physician stated she felt it was not device related.Upon follow up conversation with the physician on (b)(6) 2023 ¿ [district manager] was notified of the additional interventions and the patient had gone into organ failure and expired.This pr(b)(4): during review of video received for the related pr(b)(4); an endoleak was noted by medical director.
Additional Manufacturer Narrative
Related to pr(b)(4).
Event or Problem Description
Related: (b)(4): due to length of procedure & occlusion to renal arteries, patient¿s potassium increased.Patient was placed on dialysis.This is believed to have caused liver failure.Upon secondary cat scan, post procedure, it was believed that the sma and celiac had limited flow.Physician placed stents in each (sma, celiac) to improve blood flow.The cause is undetermined.Physician stated she felt it was not device related.Upon follow up conversation with the physician on 12/19/2023 ¿ [district manager] was notified of the additional interventions and the patient had gone into organ failure and expired.This (b)(4): during review of video received for the related (b)(4); an endoleak was noted by medical director on imaging review.
Additional Manufacturer Narrative
No part of the device was returned for evaluation.The medical director assessed this case and stated: "the video shows a large endoleak around the region of the overlap between the graft main body and the distal component, but it may also be coming from the left renal fenestration ¿ it¿s very hard to be sure from the video, despite me watching it about 50 times and stopping and starting it to see if i can determine the source of the leak.The video also shows both renal arteries are occluded, well beyond the bridging stents, due to very diseased renal arteries.Also, the coeliac trunk looks to be occluded beyond the bridging stent, and i can¿t be certain that there is any filling of the sma either.I note that the rep says both those vessels are filling, but i¿m not convinced, at least just on this one angio run and with this single view angle.I think the main problem for this poor patient is that they had very severe arterial disease, and that the procedure may well have been the ¿last straw¿ that caused the irreversible multi-vessel occlusions leading to multi-organ failure and death.I don¿t see it as a fault or failure of any of the device components.The endoleak may be due to failure of sealing between components, but the endoleak wasn¿t the cause of the patient¿s multi-organ failure or death.That was due to the multiple vessel occlusions, renal failure, liver failure, etc".Review of device history record found that work order (b)(4) appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.There were no non-conformances raised during manufacture.Review of the instructions for use (ifu) supplied with the device for general information found it contained appropriate warnings, precautions, and instructions to the user, including: potential adverse events endoleak, death.8 patient counseling information: 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.There is no evidence to suggest that the user did not follow the instructions for use.Although a definite root cause for the endoleak seen on imaging review was not able to be determined, a review of the manufacturing records did not reveal any discrepancies that could have contributed to the reported issue.The investigation concludes the complaint device was manufactured to specification.The mandatory requirement to always check complaints history during a complaint investigation will ensure trends are constantly monitored.After considering this event the benefits of using this device still outweigh the known risks.

• 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 ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 18966714
• Report Number: 9680654-2024-00022
• Device Sequence Number: 6807363
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)261116(10)AC1146853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/04/2024

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 Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1146853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female