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	G32533
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) year old male patient on (b)(6) 2019 underwent an abdominal aortic aneurysm repair procedure in which two icast stents were implanted.On (b)(6) 2020 the patient presented back to the hospital as both renal arteries were occluded and underwent a renal intervention.A renalgram was performed in the operating room.The physician tried to get a wire and catheter to track in the renals but was unsuccessful in both as due to thrombus.It has been further reported that the patient has no flow into his kidneys and is now in complete renal failure; pt is now on dialysis and is seeking to be on a kidney transplant list.The physician feels the zfen proximal device may have shifted based on pre-implant renal position vs.New renal artery position or entire device moved causing stent compression.
Event or Problem Description
It was reported that a 67 year old male patient on (b)(6) 2019 underwent an abdominal aortic aneurysm repair procedure in which two icast stents were implanted.On (b)(6) 2020 the patient presented back to the hospital as both renal arteries were occluded and underwent a renal intervention.A renalgram was performed in the o.R.The physician tried to get a wire and catheter to track in the renals but was unsuccessful in both as due to thrombus.It has been further reported that the patient has no flow into his kidneys and is now in complete renal failure; pt is now on dialysis and is seeking to be on a kidney transplant list.The physician feels the zfen proximal device may have shifted based on pre-implant renal position vs.New renal artery position or entire device moved causing stent compression.
Additional Manufacturer Narrative
The device was not returned for evaluation.Images were provided and reviewed by medical director at william cook australia.The medical director stated that cta shows clearly that there is very little, if any, downward migration of the devices, and both renal stents are open, and both are pointing downward.Significant migration of the main graft body would have dragged the renal fenestrations downwards and changed the angle of the renal stents.There is no real evidence of any graft migration.The medical director could not see any fault or failure of the endograft, and can offer no speculation as to why both renal arteries/stents seem to have spontaneously thrombosed.Both renal stents are open, but no flow through them due to thrombus within the stents.Work order ac1048041 was reviewed and appears complete and correct.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per the device order form signed by the physician.The ifu sent with the complaint device states that "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." and lists organ impairment/loss due to side-branch vessel occlusion (in particular, renal and/or gastrointestinal impairment/loss) and renal complications and subsequent attendant problems (e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure) as potential adverse events.Based on the information received it is difficult to determine an exact root cause.It is possible that one or more of the following factors contributed to the complaint: - rough surface prone to thrombus formation - 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: 10064103
• Report Number: 9680654-2020-00020
• Device Sequence Number: 14423428
• Product Code: MIH
• UDI-Device Identifier: 10827002325330
• UDI-Public: (01)10827002325330(17)221030(10)AC1048041
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 10/30/2022
• Device Model Number: G32533
• Device Catalogue Number: ZFEN-P-2-30-94-R
• Device Lot Number: AC1048041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/17/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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: Disability
• Patient Age: 67 YR