BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 614985 · Received June 17, 2005

    Report

    Report Number
    1063481-2005-00010
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    May 18, 2005
    Report Date
    June 16, 2005
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A PULMONARY VALVE WITH AN INTERNAL ANNULAR DIAMETER OF 18 MM WAS IMPLANTED IN 2005 INTO A PT WITH AN UNK MEDICAL HISTORY. AN ECHOCARDIOGRAM WAS PERFORMED THE DAY AFTER IMPLANT, WHICH REPORTEDLY INDICATED THAT THE VALVE DIAMETER WAS 25 MM. THE VALVE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A SAMLLER VALVE. THE SURGEON INDICATED THAT THE DIAMETER OF THE EXPLANTED VALVE APPEARED TO BE 21 MM. THE EXPLANTED VALVE WAS PLACED IN FORMALIN, THEN TRANSFERRED INTO AN ALTERNATE, UNK SOLUTION AND RETURNED TO CRYOLIFE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE HEART VALVE, ALLOGRAFT MIE CRYOLIFE, INC. PV00 NA

    Patients

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