BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE

    MDR report key: 2970962 · Received February 15, 2013

    Report

    Report Number
    3009024882-2013-00004
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ST. JUDE MEDICAL COSTA RICA LTDA. (CS)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO LEAKAGE WHICH INCREASED POSTOPERATIVELY, AND WAS REPLACED BY AN SJM MECHANICAL VALVE. THE SURGEON BELIEVED THE PATIENT'S SMALL AORTA WITH NO SINUS RESULTED IN PRESSURE ON STRUT AND INADEQUATE COAPTATION. THE PATIENT IS REPORTED TO BE IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69667 TRIFECTA VALVE NONE LWR ST. JUDE MEDICAL COSTA RICA LTDA. (CS) TF-19A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R