MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32561
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was discovered unconscious at home by a family member and was brought to the hospital where an imaging procedure was performed.Imaging showed that the aneurysm sac appeared to be enlarged and component separation.The patient has refused further treatment.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: 12545860
• Report Number: 3005580113-2021-00111
• Device Sequence Number: 3487883
• Product Code: MIH
• UDI-Device Identifier: 10827002325613
• UDI-Public: (01)10827002325613(17)220306(10)AC1033237
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2021
• Report Date (Section F): 09/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: G32561
• Device Catalogue Number: ZFEN-D-12-45-76-C
• Device Lot Number: AC1033237
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/01/2021
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2021
• 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
• Date Report Sent to FDA: 09/29/2021