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	G32550
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930)
Date of Event	12/19/2019
Type of Reportable Event	Death
Event or Problem Description
An (b)(6) male patient underwent a fenestrated endovascular aortic repair on the aorta on the (b)(6) 2019 in which a zenith fenestrated aaa endovascular graft proximal body, and a zenith fenestrated aaa endovascular graft distal bifurcated body, and two 6x22mm atrium icast stents were implanted.After the (b)(6) 2019 the abdominal aneurysm continued to grow around the fenestrated implant.There was separation of the icast renal stent from the proximal fenestrated graft.On the (b)(6) 2019 the patient presented with aortic rupture including separation of the right renal stent (6x22 icast) from the proximal fenestrated graft.Additional implants, three gore viabahn stents were used as well as a cook zdeg-p-38-79-pf-us & a esbe-36-50-zt & zta-p-40-117-w, were added to stop the hemorrhage but did not fix the ruptured aorta.The patient expired on the (b)(6) 2019.
Event or Problem Description
An 84 year old male patient underwent a fenestrated endovascular aortic repair on the aorta on the (b)(6) 2019 in which a zenith fenestrated aaa endovascular graft proximal body, and a zenith fenestrated aaa endovascular graft distal bifurcated body, and two 6x22mm atrium icast stents were implanted.After the (b)(6) 2019 the abdominal aneurysm continued to grow around the fenestrated implant.There was separation of the icast renal stent from the proximal fenestrated graft.On the (b)(6) 2019 the patient presented with aortic rupture including separation of the right renal stent (6x22 icast) from the proximal fenestrated graft.Additional implants, three gore viabahn stents were used as well as a cook zdeg-p-38-79-pf-us & a esbe-36-50-zt & zta-p-40-117-w, were added to stop the hemorrhage but did not fix the ruptured aorta.The patient expired on the (b)(6) 2019.
Additional Manufacturer Narrative
The device was not returned for evaluation.Additional information was received: the surgeon stated that the cause of the mortality was due to aortic infection which caused rapid expansion & ultimately, graft failure.Imaging was received and reviewed by william cook australia medical director: during the review of the imaging it has been observed little or no flaring of the proximal end of the renal stent.The work order (b)(4) was reviewed and appears complete and correct.The device ifu states: "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)"."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".Based on the available information, there is no evidence to indicate that a device non-conformance or deficiency contributed to the complaint.It is possible that one or more of the following factors contributed to the complaint: - inadequate spacing between stents/ flaring - patient factors.- procedural factors.

• 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: 9583143
• Report Number: 9680654-2020-00004
• Device Sequence Number: 328203
• Product Code: MIH
• UDI-Device Identifier: 10827002325507
• UDI-Public: (01)10827002325507(17)220923(10)AC1045302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 09/23/2022
• Device Model Number: G32550
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Device Lot Number: AC1045302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: Death
• Patient Age: 84 YR