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

Patient Problem Failure of Implant (1924)

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was learned that an on-x valved conduit was explanted at implant.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: 18320434
• MDR Text Key: 331721539
• Report Number: MW5149206
• 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: Other
• Type of Report: Initial
• Report Date: 12/11/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Patient Sequence Number: 1