BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASTERS SERIES HEMODYNAMIC PLUS W/ SILZONE COATING

    MDR report key: 348752 · Received August 27, 2001

    Report

    Report Number
    2648612-2001-00285
    Event Type
    Death
    Date Received
    August 27, 2001
    Date of Event
    September 29, 2000
    Report Date
    August 27, 2001
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE AUTOPSY REPORT, THE CAUSE OF DEATH WAS DETERMINED TO BE "MASSIVE" CHF. THE PATIENT WAS A PARTICIPANT IN THE AVERT. PATIENT WAS REHOSPITALIZED IN 1999 WITH "MILD" CHF THAT WAS RESOLVED WITH FUROSEMIDE AND DIURESIS. IN 2000, ECHO SHOWED MILD TO MODERATE AORTIC REGURGITATION AND A POSSIBLE "SMALL" PARAVALVULAR LEAK; HOWEVER, THE PATIENT WAS NOTED TO BE "DOING WELL" AND NO MEDICATION CHANGES WERE MADE. IN 2000, "TEE" INDICATED A "WELL SEATED VALVE" WITH A "LARGE" PARAVALVULAR LEAK AND "SEVERE" LEFT VENTRICLE DYSFUNCTION, AND REOPERATION WAS ANTICIPATED BUT NOTED TO BE "HIGH RISK". PT WAS TREATED WITH A COURSE OF ANTIBIOTICS DESPITE THE ABSENCE OF FEVER AND CHILLS AND AMLODIPINE AND SPIRONOLACTONE WERE STARTED. A "TEE" 12 DAYS LATER REVEALED "SIGNIFICANT" AORTIC REGURGITATION, AND THE PATIENT SUBSEQUENTLY EXPIRED AT HOME LATER IN 2000. AT AUTOPSY, THE VALVE WAS INTACT WITH "EVIDENCE OF SOME SPACE IN THE PARAVALVULAR AREA WHERE PARAVALVULAR LEAK LIKELY OCCURRED". IT IS UNKNOWN IF THE VALVE WAS EXPLANTED AT AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38847 MASTERS SERIES HEMODYNAMIC PLUS W/ SILZONE COATING ROTATABLE HP W/ SILZONE LWQ ST. JUDE MEDICAL, INC. 25AHPS-605 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death