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
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041); No Code Available (3191)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
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.

• 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: 10043569
• Report Number: 3005580113-2020-00361
• Device Sequence Number: 11378764
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 67 YR