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 G32538

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2023

Event Type  Injury  

Event Description

The zfen device appeared difficult to read under flouro while performing a/p confirmation.Anterior markers remained at/near 12 o¿clock position orientation throughout a 360-degree rotation, as well as small fen markers appeared difficult to confirm orientation.Upon unsheathing, the graft appeared severely twisted, causing miss-alignment and inevitable explant.

• 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: 17339742
• MDR Text Key: 319383740
• Report Number: 3005580113-2023-00093
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325385
• UDI-Public: (01)10827002325385(17)260427(10)AC1133002
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2023

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
• Device Operator: Health Professional
• Device Model Number: G32538
• Device Catalogue Number: ZFEN-P-2-30-109-R
• Device Lot Number: AC1133002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2023
• Distributor Facility Aware Date: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2023
• Date Device Manufactured: 04/27/2023
• 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: 80 YR
• Patient Sex: Female