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	G32542
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Originally stent was implanted on (b)(6) 2021.2 icast stents were also implanted both of 6x22, placed one on each side of renals respectively (left and right).Notice narrowing on (b)(6) 2021 of the superior mesenteric artery (sma) and the celiac artery with decreased flow.This required stenting of both arteries but information of stents used is unknown.Twisting may have contributed to the occurred event, but this cannot be determined.No twisting occurred during the original procedure.

• 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: 13097849
• Report Number: 3005580113-2021-00155
• Device Sequence Number: 11810208
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)231116(10)AC1069091
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2021
• Report Date (Section F): 12/28/2021

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: 11/16/2023
• Device Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Device Lot Number: AC1069091
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2021
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2021
• Date Device Manufactured: 11/16/2020
• 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 Age: 62 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/28/2021