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

Patient Problem Pseudoaneurysm (2605)

Event Date 10/17/2023

Event Type  Injury  

Event Description

It was learned that a patient with a non-edwards 23mm on-x mechanical valve developed large lvot pseudoaneurysm approximately 1 year post implant and had extensive testing, but no clear etiology/mechanism for the mechanical valve failure and presumed culture negative endocarditis.She underwent redo bio bentall (10/17/2023) and the mechanical valve was replaced with a 25mm edwards aortic valved-conduit.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ON-X PROSTHETIC HEART VALVE AND ASCENDING AORTIC PROTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.
• MDR Report Key: 18211720
• MDR Text Key: 329261716
• Report Number: MW5148519
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1