MAUDE Adverse Event Report: ST. JUDE MEDICAL MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Patient Problem Failure of Implant (1924)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Through edwards implant patient registry and investigation, it was learned a st.Jude mechanical valve (implanted in 2013) was explanted due to unknown reasons and replaced with a 23mm 11500a aortic valve.Patient post-operative status noted as in recovery.Patient: 71-year-old female."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".

• Brand Name: MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 18133107
• MDR Text Key: 328226641
• Report Number: MW5148110
• 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: 11/09/2023

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: 11/13/2023
• Patient Sequence Number: 1