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	G32536
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The original implant on (b)(6) 2019 was successful.The follow up ct showed no issues, all vessels were noted to be patent.The patient was released from hospital.19 days post procedure, on (b)(6) 2019 the patient presented with thrombosed left renal and superior mesenteric artery (sma) stents.The doctor performed an emergent superior mesenteric artery (sma) bypass.
Event or Problem Description
The original implant on (b)(6) 2019 was successful.The follow up ct showed no issues, all vessels were noted to be patent.The patient was released from hospital.19 days post procedure, on (b)(6) 2019 the patient presented with thrombosed left renal and superior mesenteric artery (sma) stents.The doctor performed an emergent superior mesenteric artery (sma) bypass.
Additional Manufacturer Narrative
The device was not returned for evaluation and remains in-situ.Work order (b)(4) was reviewed and appears complete and correct.Images were provided and reviewed by medical director at william cook australia: "the patient had a zfen implanted on (b)(6) 2019, and the proximal component of the main body consisted of two 6mm renal fenestrations, one 8mm superior mesenteric artery (sma) fenestration, and a single-width (10mm wide) scallop for the coeliac trunk.The coeliac scallop extended down alongside the sma fenestration and very close to it.I don¿t have the distance marked on the planning documents, but it looks to be 1-2mm away from the sma fenestration.The patient¿s anatomy on ct scan shows the coeliac trunk arising very close to the sma origin ¿ not quite a common origin but very close.The completion ct angiogram done the day after the procedure shows a couple of potential problems.The left renal bridging stent looks to be lying further back into the main graft body than usual, and doesn¿t look to be flared much.It¿s hard to say on the definition of the scans available whether or not there is any crushing or deformity of the left renal stent.It is lying up against the anterior wall of the main graft body.The coeliac trunk (unstented) looks to be quite narrow at its origin, possibly from compression by the very-closely adjacent sma stent.There is flow in the coeliac trunk, but with the marked narrowing at its origin.The sma stent is hard to define accurately on the definition of the scans available, but there appears to be some distortion - crushing ¿ of the sma stent proximal end where it projects into the main graft body.The possible deformity of the sma stent proximal end, and the fact that the left renal stent may have been projecting too far back into the main graft body, may well have been factors in the thrombosis of both the left renal and the sma." the device ifu states: "arterial or venous thrombosis and/or pseudoaneurysm" is listed as a potential adverse event.¿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.¿ from the information received in this complaint it is difficult to determine a definitive root cause.It is possible that one or more of the following factors may have contributed to the complaint: rough surface prone to thrombus formation.Inadequate medication of patient with anticoagulants.Patient anatomy/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: 8475693
• Report Number: 9680654-2019-00011
• Device Sequence Number: 1474447
• Product Code: MIH
• UDI-Device Identifier: 10827002325361
• UDI-Public: (01)10827002325361(17)220109(10)AC1029919
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/23/2019

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: 01/09/2022
• Device Model Number: G32536
• Device Catalogue Number: ZFEN-P-2-26-109-R
• Device Lot Number: AC1029919
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7X27 MEDTRONIC VISI-PRO. 6X2 ATRIUM ICAST RENAL(2); 7X27 MEDTRONIC VISI-PRO. 6X2 ATRIUM ICAST RENAL(2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR