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

Patient Problem Failure of Implant (1924)

Event Date 09/03/2023

Event Type  malfunction  

Event Description

It was learned that a 19 mm st.Jude mechanical valve was implanted on (b)(6) 2017 and explanted on (b)(6) 2023.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/ABBOTT MEDICAL
• MDR Report Key: 18240434
• MDR Text Key: 329482047
• Report Number: MW5148612
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Patient Sequence Number: 1