MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Event Date 03/26/2024

Event Type  Death  

Event Description

Per the vascular surgeon's op note: infrarenal abdominal aortic aneurysm rupture, in the setting of prior cook z-fen endograft repair in 2019 at outside hospital.Intraoperative findings were consistent with a type iii endoleak-endograft component separation - likely causing the sac expansion and eventual rupture.The pt expired.

• Brand Name: UNKNOWN
• 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: 19203741
• MDR Text Key: 341296101
• Report Number: 3005580113-2024-00027
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2024
• Distributor Facility Aware Date: 04/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2024
• 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): Death