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	G32534
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
No problem with the device was alleged.One day after placement, the patient developed bowel ischemia.The patient required surgery for bowel (colon) resection and colostomy.Further information provided, the patient expired a few days after the procedure.
Event or Problem Description
No problem with the device was alleged.One day after placement, the patient developed bowel ischemia.The patient required surgery for bowel (colon) resection and colostomy.Further information provided, the patient expired a few days after the 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: 12838514
• Report Number: 3005580113-2021-00141
• Device Sequence Number: 4529075
• Product Code: MIH
• UDI-Device Identifier: 10827002325347
• UDI-Public: (01)10827002325347(17)240908(10)AC1086714
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• Report Date (Section F): 11/15/2021

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: 09/08/2024
• Device Model Number: G32534
• Device Catalogue Number: ZFEN-P-2-32-94-R
• Device Lot Number: AC1086714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2021
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2021
• Date Device Manufactured: 09/08/2021
• 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: Male