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 G32539

Device Problem Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 05/24/2023

Event Type  Injury  

Event Description

Per rep - (b)(6) 2023 - everything was deployed correctly.The main wire that the device was deployed over got pulled back.Then they rewired into the device and put up a coda balloon which would not track over the wire through the device.At that point, they took an angiogram and realized that the device had twisted and covered the sma and right renal artery.At that point, the physician decided to do an open repair.The patient lived coming off the table.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: 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: 17108016
• MDR Text Key: 317132216
• Report Number: 3005580113-2023-00069
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)260328(10)AC1131033
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G32539
• Device Catalogue Number: ZFEN-P-2-32-109-R
• Device Lot Number: AC1131033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Distributor Facility Aware Date: 05/24/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2023
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male