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	G32537
Health Effect - Clinical Codes	Renal Failure (2041); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The original procedure was performed in (b)(6) 2018.During (b)(6) 2018 computed tomography angiography, it was observed that little to no contrast was traveling to the left renal artery.The gore vbx balloon expandable stent that was implanted along with the cook fenestrated graft and is supposed to keep cook's stent aligned with the renal artery.The renal appears to have possibly shut down.The physician plans duplex ultrasound of renal to determine bloodflow to left kidney.
Event or Problem Description
The original procedure was performed in (b)(6) 2018.During (b)(6) 2018 computed tomography angiography, it was observed that little to no contrast was traveling to the left renal artery.The gore vbx balloon expandable stent that was implanted along with the cook fenestrated graft and is supposed to keep cook's stent aligned with the renal artery.The renal appears to have possibly shut down.The physician plans duplex ultrasound of renal to determine bloodflow to left kidney.
Additional Manufacturer Narrative
The device was not returned for evaluation and remains in-situ.Medical imaging provided for this case were reviewed by the william cook australia medical director: "on the pre-op ct scans, it appears that there is a fairly acute, posteriorly-directed angle in the left renal artery, with a calcific plaque at the angle, almost immediately adjacent to the wall of the aorta.On the 6-monthly post-op ct scan, this angle is apparent once again, but now with the left renal stent traversing it, and hence this is kinked (gore viabahn stent).There is also some suggestion that there may be some ¿crushing¿ of the left renal stent inside the lumen of the main body graft, on the inside of the fenestration.This may just be that insufficient flaring of the viabahn stent was carried out.I suspect, however, that the flow in the left renal artery was already compromised on the pre-op ct scan, most likely by the kink in the artery as mentioned above, and that placement of the stent may also have added a degree of intimal hyperplasia at its end that ultimately stopped the flow.There does appear to be some contrast within the stent on the follow-up ct scan, but nothing beyond it.I think this problem is the result of an inadequate left renal artery from the outset, with a calcified kink already present, and then exacerbated by stent placement and possibly some intimal hyperplasia at the end of the stent.I can¿t see any fault or failure of the main graft body device." work order ac1016106 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." "inappropriate patient selection may result in poor performance of the zenith fenestrated aaa endovascular graft with the h&l-b one-shot introduction system." "access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease, and/or calcification) should be compatible with vascular access techniques and delivery systems of the profile of a 14 french to 22 french vascular introducer sheath.Iliac conduits may be used to ensure the safe insertion of the introduction system.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization/trauma." "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 available in this complaint, it is most likely that the one or more of the following factors contributed to the complaint: - kink in the balloon expandable stent at the renal artery - patient anatomy (kinked renal artery with calcific plaque) - procedural factors (e.G., intimal hyperplasia) - inadequate medication of patient with anti-coagulants.

• 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: 8283209
• Report Number: 9680654-2019-00002
• Device Sequence Number: 13967297
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)210424(10)AC1016106
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 04/24/2021
• Device Model Number: G32537
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC1016106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/28/2019
• 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: Disability