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	G32542
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-procedure, the left renal shutdown.During the case, the left renal was dissected.It is believed to be the likely cause of the renal shutdown.No secondary intervention on the left renal was performed after it shutdown.
Event or Problem Description
Post-procedure, the left renal shutdown.During the case, the left renal was dissected.It is believed to be the likely cause of the renal shutdown.No secondary intervention on the left renal was performed after it shutdown.
Additional Manufacturer Narrative
The device was not returned for evaluation and remains in-situ.Images were provided and reviewed by medical director at (b)(6) australia: "the only ct scans we have are the pre-procedural scans.We do, however, have the operative fluoroscopy angiograms, and they show that everything seemed to proceed well.On the operative imaging, i cannot see any signs of a dissection in the selection of images provided, and on the last completion angio run, there is very good flow to both kidneys via both renal arteries.I cannot see the cause or the occurrence of the left renal shutdown, and we don¿t have later images that may have shown the left renal artery as the cause of the problem.I can only surmise that any left renal occlusion may indeed have been caused by procedural maneuvering of wires, catheters, stent, etc, and that it was not due to any fault or failure in the device." work order: (b)(4) was reviewed and appears complete and correct.The device ifu 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." "potential adverse events that may occur and/or require intervention include, but are not limited to: renal complications and subsequent attendant problems (e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure)." from the information received in this complaint it is difficult to determine an exact root cause.It is possible that one or more of the following factors could have contributed to the complaint: twisting of implant within the delivery system kinking/collapse/excessive prolapse of graft/folding of graft material between stents collapse of graft due to stent fracture.Rough surface prone to thrombus formation.Inadequate medication of patient with anti-coagulants inadequate spacing between stents procedural related factors contributing to dissection of the kidney, resulting in occlusion of the vessel.

• 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 8123191
• Report Number: 9680654-2018-00035
• Device Sequence Number: 19414557
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)210927(10)AC1024506
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 09/27/2021
• Device Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Device Lot Number: AC1024506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 67 YR