BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM TRIFECTA STENTED TISSUE VALVE

    MDR report key: 3060062 · Received April 5, 2013

    Report

    Report Number
    3009024882-2013-00009
    Event Type
    Death
    Date Received
    April 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL COSTA RICA LTDA. (CS)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH AORTIC REGURGITATION, STENOSIS, AN ELEVATED GRADIENT, AND INFECTIOUS ENDOCARDITIS. DESPITE ANTIBIOTIC TREATMENT, THE PT DIED. THE AUTOPSY REVEALED BACTERIA FLORA SURROUNDING THE VALVE AND BLOOD CULTURE RESULTS WERE POSITIVE FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139837 SJM TRIFECTA STENTED TISSUE VALVE NONE LWR ST. JUDE MEDICAL COSTA RICA LTDA. (CS) TF-21A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H