MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE; HEART-VALVE, MECHANICAL

Patient Problem Insufficient Information (4580)

Event Date 02/19/2024

Event Type  Death  

Event Description

It was learned that a patient with on-x aortic valve expired on pod#4.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Post operation day number four.

• Brand Name: ON-X AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.
• MDR Report Key: 18902013
• MDR Text Key: 337636243
• Report Number: MW5152810
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death