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	G32535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This (b)(4): left renal stent occluded, infarcted kidney, patient on dialysis.Mentioned that the stent used for renal artery was 5mm stent (non-cook).The physician mentioned that the only zfen renal occlusions he has seen have occurred when 5mm stent was used in the renal.See (b)(4) for: 2 other patients receiving 5mm stent have occluded.(totalling 3 out of 4 patients who received a 5mm stent).

• 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 ; AS
• MDR Report Key: 17298355
• Report Number: 3005580113-2023-00084
• Device Sequence Number: 20585355
• Product Code: MIH
• UDI-Device Identifier: 10827002325354
• UDI-Public: (01)10827002325354(17)260328(10)AC1130882
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023
• Report Date (Section F): 07/11/2023

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: 03/28/2026
• Device Model Number: G32535
• Device Catalogue Number: ZFEN-P-2-24-109-R
• Device Lot Number: AC1130882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2023
• Date Device Manufactured: 03/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/11/2023