BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 190836 · Received October 7, 1998

    Report

    Report Number
    1063481-1998-00022
    Event Type
    Injury
    Date Received
    October 7, 1998
    Date of Event
    April 7, 1997
    Report Date
    September 8, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVEN MONTH OLD MALE WITH MEDICAL HISTORY OF TETROLOGY OF FALLOT AND DIGEORGE SYNDROME UNDERWENT RIGHT VENTRICLE OUTFLOW TRACT PROCEDURE USING A 13MM AORTIC HOMOGRAFT AND VENTRICULAR SEPTAL DEFECT CLOSURE ON 12/21/1992. ON 04/07/1997, PT HAD VALVE EXPLANTED AND REPLACED WITH A 19MM AMERICAN RED CROSS HOMOGRAFT DUE TO LARGE GRADIENT AND OBSTRUCTION. OPERATIVE REPORT NOTES VALVE WAS CALCIFIED AND LEAFLETS WERE TOTALLY ABSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE Implant HEART VALVE, ALLOGRAFT MIE CRYOLIFE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| L| R