BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 191063 · Received October 9, 1998

    Report

    Report Number
    1063481-1998-00026
    Event Type
    Injury
    Date Received
    October 9, 1998
    Date of Event
    September 8, 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 YEAR OLD MALE WITH MEDICAL HISTORY OF AORTIC STENOSIS AND TUNNEL OBSTRUCTION STATUS POST "ONE STAGE REPAIR" OF INTERRUPTED AORTIC ARCH AND VENTRICULAR SEPTAL DEFECT UNDERWENT A ROSS PROCEDURE USING A 16MM PULMONARY HOMOGRAFT ON 02/20/1995. ON 09/O8/1997, PT HAS REOPERATED TO EXPLANT STENOSED PULMONARY CONDUIT (REPLACED WITH 19MM HOMOGRAFT) AND TO REPAIR INSUFFICIENT AUTOGRAFT.

    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 3 YR Hospitalization| L| R