BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 190831 · Received October 7, 1998

    Report

    Report Number
    1063481-1998-00024
    Event Type
    Injury
    Date Received
    October 7, 1998
    Date of Event
    June 2, 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

    ONE WEEK OLD MALE WITH MEDICAL HISTORY OF TRUNCUS ARTERIOSUS, INTERRUPTED AORTIC ARCH AND VENTRICULAR SEPTAL DEFECT UNDERWENT RIGHT VENTRICULAR OUTFLOW TRACT USING A 9MM PULMONARY HOMOGRAFT AND VENTRICULAR SEPTAL DEFECT REPAIR ON 01/08/1996. ON 06/02/1997, PT HAD VALVE EXPLANTED AND REPLACED WITH 19MM PULMONARY HOMOGRAFT DUE TO OUTGROWTH AND FIBROTIC OBSTRUCTION AT INSERTION INTO RIGHT VENTRICLE. OPERATIVE RECORD NOTES CONDUIT WAS NOT CALCIFIED.

    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 17 MO Hospitalization| R