BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASTERS SERIES HEMODYNAMIC PLUS VALVE

    MDR report key: 281045 · Received June 9, 2000

    Report

    Report Number
    2648612-2000-00177
    Event Type
    Death
    Date Received
    June 9, 2000
    Date of Event
    May 30, 2000
    Report Date
    June 9, 2000
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER PATHOLOGY REPORT: THE VALVE MEASURED 2 CM IN DIAMETR AND CONTAINED 2 SEMICIRCULAR DISKS WITHIN THE SEWING RING SURROUNDED BY A RIM OF TISSUE. THERE WAS VEGETATION AND THROMBI ON THE VALVE. THERE WERE ALSO FRAGMENTS OF YELLOW-TAN TISSUE, MEASURING 7X7X1.4 CM IN AGGREGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTERS SERIES HEMODYNAMIC PLUS VALVE ROTATABLE HP VALVE LWQ ST. JUDE MEDICAL, INC. 21AHPJ-505 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death