BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 618483 · Received June 8, 2005

    Report

    Report Number
    1063481-2005-00008
    Event Type
    Other
    Date Received
    June 8, 2005
    Date of Event
    December 23, 2003
    Report Date
    June 8, 2005
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SYNERGRAFT PULMONARY VALVE AND CONDUIT, WAS IMPLANTED IN 2003 INTO A PT WITH AN UNKNOWN MEDICAL HISTORY. CRYOLIFE RECEIVED A RECALL SUMMARY CARD FROM THE IMPLANT FACILITY IN 5/2003 THAT STATED, "THIS TISSUE WAS REMOVED 2003." THE REPORTING RN WAS CONTACTED BY CRYOLIFE IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EXPLANT OF THIS VALVE. SHE STATED THAT THE VALVE WAS EXPLANTED IN A PLANNED PORCEDURE BECAUSE IT WAS "TIME FOR IT TO COME OUT". SHE ALSO INDICATED THAT THE VALVE WAS STENOTIC AND CALCIFIED. HOWEVER, THERE WERE NO PT SYMPTOMS ATTRIBUTED TO THE VALVE THAT PROMPTED THE REOPERATION. THE REPORTING RN WAS NOT ABLE TO GIVE ANY ADDITIONAL INFORMATION REGARDING THE IMPLANT OR REMOVAL OF THE PULMONARY VALVE AND CONDUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE HEART VALVE, ALLOGRAFT MIE CRYOLIFE, INC. SGPV00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Other