MAUDE Adverse Event Report: ST. JUDE HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Gradient Increase (1270)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that approximately 4 years and 5 months post implant of a st.Jude tf-21a surgical valve, the valve was replaced with an unknown valve due to increasing aortic valve gradients.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: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17522973
• MDR Text Key: 321421334
• Report Number: MW5129921
• Device Sequence Number: 1
• Product Code: LWR
• 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: 03/26/2019

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