BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 472077 · Received July 16, 2003

    Report

    Report Number
    1063481-2003-00077
    Event Type
    Other
    Date Received
    July 16, 2003
    Date of Event
    June 18, 2003
    Report Date
    June 18, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003 A PT OF UNKNOWN MEDICAL HISTORY UNDERWENT PULMONARY VALVE REPLACEMENT (PROCEDURE UNSPECIFIED) WITH A CRYOPRESERVED PULMONARY VALVE AND CONDUIT SG. ACCORDING TO THE SURGEON'S INCIDENT REPORT TO THE MFR, AT APPROX 1 HOUR INTO THE PROCEDURE THE VALVE WAS EXPLANTED SECONDARY TO UNSATISFACTORY TISSUE QUALITY. SPECIFICALLY, THE SURGEON DESCRIBED THE VALVE TISSUE AS FRIABLE AND REPORTED THAT THE ALLOGRAFT POSSESSED A TEAR IN THE INTIMAL LAYER OF THE CONDUIT NEAR THE SINUS. ACCORDING TO IMPLANT RECORDS, THE PT WAS PLACED BACK ON BYPASS AND A SECOND CRYOPRESERVED PULMONARY VALVE AND CONDUIT SG WAS THAWED AND IMPLANTED WITH NO FURTHER COMPLICATIONS REPORTED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| O| R