MAUDE Adverse Event Report: ABBOTT / ST. JUDE MEDICAL, INC. TRIFECTA 23 AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Patient Problem Unspecified Infection (1930)

Event Date 02/28/2023

Event Type  Injury  

Event Description

(b)(6), 2017 had aortic valve surgery with trifecta 23 aortic valve.Two weeks later, additional surgery required, had infection and doctor.Removed sternum.Had to have tavr(transcatheter aortic valve replacement) to replace the trifecta 23 on (b)(6) 2023 due to issues with trifecta valve.This is just a glimpse of what i have been through since my 1st savr in 2017.Please feel free to contact us if you have any questions.

• Brand Name: TRIFECTA 23 AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT / ST. JUDE MEDICAL, INC.
• MDR Report Key: 17624423
• MDR Text Key: 322105530
• Report Number: MW5144960
• Device Sequence Number: 1
• Product Code: LWR
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White