BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBIS UNIVERSAL VALVE

    MDR report key: 588857 · Received April 7, 2005

    Report

    Report Number
    1627803-2005-00001
    Event Type
    Injury
    Date Received
    April 7, 2005
    Date of Event
    December 22, 2004
    Report Date
    April 7, 2005
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SIZE 27 CARBOMEDICS ORBIS CPHV WAS IMPLANTED WITH COMPLETE PRESERVATION OF THE CHORDAE TENDINAE. TRICUSPID ANNULOPLASTY WAS ALSO PERFORMED. FOUR DAYS LATER A SERIES OF ECHOCARDIOGRAMS REVEALED A HIGH GRADIENT ACROSS THE MITRAL PROSTHESIS, NORMAL MOVEMENT OF ONE LEAFLET AND NO MOTION OF THE ANTERIOR LEAFLET. REOPERATION FOUND THE MITRAL PROSTHESIS WITH THE ANTERIOR LEAFLET TO BE MOTIONLESS AND SURROUNDED BY A "FIRM COAGULUS EXPLANDING UP TO 1 CM" OUTSIDE OF THE VALVE. THE VALVE WAS EXPLANTED WITH NO OBSERVATIONS BY THE SURGEON OF "LOCK UP" BY CHORDAE OF SUBVALVULAR APPARATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIS UNIVERSAL VALVE PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. 200 A622464-D

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R