BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE TRIFECTA VALVE

    MDR report key: 19467628 · Received June 4, 2024

    Report

    Report Number
    MW5155723
    Event Type
    Death
    Date Received
    June 4, 2024
    Date of Event
    March 20, 2024
    Report Date
    June 1, 2024
    Manufacturer
    ABBOTT / ST. JUDE MEDICAL
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY DAUGHTER RECEIVED THE ST JUDE TRIFECTA VALVE (B)(6) 2017. SHE DID FINE UP UNTIL 8-10 MONTHS AGO. SHE DEVELOPED FATIGUE, SHORTNESS OF BREATH, AND EDEMA. IT TOOK HER 6 MONTHS GET IN TO BE SEEN BY A CARDIOLOGIST. WHEN SHE FINALLY DID, SHE WAS IN SEVERE HEART FAILURE. SHE HAD AN ECHO COMPLETED AND HER EJECTION FRACTION HAD REDUCED TO 20% AND HER IMPLANTED AORTIC VALVE WAS SEVERELY STENOTIC. SHE WAS TRANSFERRED TO A HIGHER LEVEL OF CARE. SHE UNDERWENT OPEN HEART SURGERY (B)(6) 2024. SHE REQUIRED ECHMO AND A PUMP. HER CHEST WAS NEVER ABLE TO BE CLOSED. SHE FOUGHT FOR 10 DAYS AND PASSED AWAY (B)(6) 2024. (B)(6) HOSPITAL IN (B)(6) SHOULD HAVE PICTURES OF THE VALVE. I DO NOT KNOW IF THEY KEPT OF VALVE OR SENT IT FOR PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802917 ST JUDE TRIFECTA VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT / ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Death| H LABETALOL