BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 337680 · Received June 14, 2001

    Report

    Report Number
    6000026-2001-00003
    Event Type
    Death
    Date Received
    June 14, 2001
    Date of Event
    May 8, 2001
    Report Date
    May 16, 2001
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT FOLLOWING PLACEMENT OF AORTIC AND MITRAL VALVES, THE PT'S LEFT ATRIUM PRESSURE WAS HIGH. THE AORTA WAS CROSS-CLAMPED AND THE VALVE WAS RE-ORIENTED BUT THE PRESSURE REMAINED HIGH. ECHO REVEALED THAT BOTH THE MITRAL & AORTIC VALVES WERE FUNCTIONING INSUFFICIENTLY. THE VALVES WERE REMOVED AND REPLACED. THE LEFT ATRIUM PRESSURE DESCENDED SLOWLY. FOLLOWING SURGERY, THE PT HAD LOW CARDIAC OUTPUT AND EXPIRED THE NEXT DAY. THIS IS THE SAME PT AS REPORT # 6000026-2001-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27178 MEDTRONIC HALL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ MEDTRONIC HEART VALVES, INC. M7700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death| R