BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 525640 · Received February 19, 2004

    Report

    Report Number
    1063481-2004-00091
    Event Type
    Other
    Date Received
    February 19, 2004
    Date of Event
    December 15, 2003
    Report Date
    January 14, 2004
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE CRYOPRESERVED PULMONARY VALVE & CONDUIT WAS IMPLANTED INTO A PT OF UNKNOWN MEDICAL HISTORY DURING VALVE REPLACEMENT SURGERY (TYPE UNKNOWN). A REPORT FROM THE DISTRIBUTOR INDICATES THAT THE VALVE WAS SUBSEQUENTLY EXPLANTED ABOUT FOUR MONTHS LATER, SECONDARY TO EARLY DEGENERATION OF THE PULMONARY VALVE, CHARACTERIZED BY A LOSS OF ENDOTHELIAL CELLS, SECONDARY SECRETION OF FIBRIN AND RESORBING AND SCARRING GRANULATION TISSUE. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER CRYOPRESERVED PULMONARY VALVE & CONDUIT AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE HEART VALVE, ALLOGRAFT MIE CRYOLIFE, INC. NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| O| R