MAUDE Adverse Event Report: ST. JUDE SIZER, HEART-VALVE, PROSTHESIS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Type  Injury  

Event Description

Medtronic received information, that st.Jude mitral valve replacement was performed on (b)(6) 2015.A (b)(6) and (b)(6) month later, a transesophageal echocardiography test (tee) showed severe mitral valve paravalvular leak.And was scheduled for a mitral valve replacement.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIZER, HEART-VALVE, PROSTHESIS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17534643
• MDR Text Key: 321145347
• Report Number: MW5141544
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1