BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 191059 · Received October 9, 1998

    Report

    Report Number
    1063481-1998-00028
    Event Type
    Injury
    Date Received
    October 9, 1998
    Date of Event
    April 6, 1998
    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

    TWO WEEKS OLD MALE WITH MEDICAL HISTORY OF TRUNCUS ARTERIOSUS TYPE I AND VENTRICULAR SEPTAL DEFECT REPAIR ON 01/04/1996. ON 04/06/1998, PT HAD VALVE EXPLANTED DUE TO OUTGROWTH AND CALCIFICATION. THE VALVE WAS REPLACED WITH AN 18MM PULMONARY HOMOGRAFT.

    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 27 MO Hospitalization| L| R