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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Multiple Organ Failure (3261)

Event Date 12/19/2023

Event Type  Death  

Event Description

The patient had a zenith fenestrated aaa endovascular graft proximal body implanted.Due to length of procedure & occlusion to renal arteries, patient¿s potassium levels increased.The patient was placed on dialysis which is believed to have caused liver failure.Upon secondary cat scan performed post procedure, it was believed that the superior mesenteric artery (sma) and celiac artery had limited flow.The physician placed stents in each (sma and celiac artery) to improve the blood flow.The cause is undetermined but the physician stated she did not consider it to be device related.Upon follow up conversation with the physician on (b)(6) 2023, the district manager was notified of the additional interventions and that the patient had gone into organ failure and expired.

Event Description

The patient had a zenith fenestrated aaa endovascular graft proximal body implanted.Due to length of procedure & occlusion to renal arteries, patient¿s potassium levels increased.The patient was placed on dialysis which is believed to have caused liver failure.Upon secondary cat scan performed post procedure, it was believed that the superior mesenteric artery (sma) and celiac artery had limited flow.The physician placed stents in each (sma and celiac artery) to improve the blood flow.The cause is undetermined but the physician stated she did not consider it to be device related.Upon follow up conversation with the physician on (b)(6) 2023, the district manager was notified of the additional interventions and that the patient had gone into organ failure and expired.

Manufacturer Narrative

The following additional information was received: icast stents into renal arteries; bsc balloon expandable stents into celiac and superior mesenteric artery (sma) were also used during the procedure.The physician has advised that the patient was not healthy; renal arteries were small and calcified.The instructions for use (ifu) was followed for this procedure.The case was very challenging and took longer than expected which added to the health issues.No part of the procedure was performed off-label.Deployment was fine/cannulation was difficult.The patient¿s anatomy was mildly tortuous.The patient was on heparin during the procedure.The device was inspected prior to use to ensure no damage has occurred.The patient returned to operating room to have the bsx stents placed into the celiac and sma post procedure.Right renal artery (rra) had no flow post icast deployment.Difficulties experienced in the initial implant procedure: cannulation of renal artery, especially the rra.There was not any pre-existing thrombus in the patient prior to the procedure.No non-conformance of the graft identified.The patient had pre-existing calcification in rra.The medical director reviewed the video provided 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 information 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 patient is that they had very severe arterial disease, and that the procedure may well have been the ¿last straw¿ with 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: review of device history record (dhr) for work order (b)(4) found that the work order appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.Review of specifications found that there are a number of controls and processes in place that would identify faulty product prior to shipping.Review of instructions for use (ifu) supplied with the device for general information was found to contain appropriate warnings, precautions, and instructions to the user, including: 5.Adverse events potential adverse events that may occur and/or require intervention include, but are not limited to: organ impairment/loss due to side-branch vessel occlusion (in particular, renal and/or gastrointestinal impairment/loss) renal complications and subsequent attendant problems (e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure) death 8.Patient counseling information long-term performance of fenestrated endovascular grafts and stents in the 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.A review of the manufacturing records did not reveal any discrepancies that could have contributed to the reported issue.The investigation concluded that the complaint device was manufactured to specification.A definitive root cause could not be determined from the investigation.Possible root causes are patient's very severe arterial disease and/or procedural related factors.After considering this event the benefits of using this device still outweigh the known risks.The mandatory requirement to always check complaints history during a complaint investigation will ensure trends are constantly monitored.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: 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: 18407318
• MDR Text Key: 331471743
• Report Number: 9680654-2023-00148
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)261116(10)AC1146853
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Female