MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY

Model Number	G32554
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/31/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According into the initial reporter, during a fenestrated abdominal zfen procedure, upon the final run the sma and celiac were not visualized.The physician believes the initial procedure was cause for an additional procedure; the patient had to have open abdominal surgery.(the patient¿s abdomen was opened to try to stent the sma retrograde.) patient passed after he was moved from the or table.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• 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: 9394787
• Report Number: 3005580113-2019-00816
• Device Sequence Number: 2852372
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)221002(10)AC1045995
• 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: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2019
• Report Date (Section F): 12/02/2019

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: No Information
• Device Expiration Date: 10/02/2022
• Device Model Number: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1045995
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2019
• 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: Death
• Patient Age: 76 YR
• Date Report Sent to FDA: 12/02/2019