BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 474696 · Received July 30, 2003

    Report

    Report Number
    1063481-2003-00080
    Event Type
    Other
    Date Received
    July 30, 2003
    Date of Event
    April 27, 2001
    Report Date
    June 30, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2001 A PATIENT WITH HISTORY OF AORTIC VALVE DISEASE UNDERWENT A VALVE REPLACEMENT PROCEDURE (TYPE UNKNOWN) INVOLVING IMPLANTATION OF THE CRYOPRESERVED AORTIC VALVE & CONDUIT. ACCORDING TO THE USER FACILITY MDR SENT TO THE MANUFACTURER, THE PATIENT DEVELOPED ENDOCARDITIS AND WAS READMITTED IN APRIL, 2001 WITH DIAGNOSIS OF UNSPECIFIED ENDOCARDITIS. IT IS INDICATED THAT THE INFECTIOUS DISEASE PHYSICIAN COULD NOT IDENTIFY THE SOURCE OF THE INFECTION BUT WAS CONCERNED ABOUT THE ALLOGRAFT VALVE PLACED 2 MONTHS PRIOR. THE VALVE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT IN 2001 AND REPLACED WITH A SECOND AORTIC VALVE ALLOGRAFT (SAME MANUFACTURER).

    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 77 YR Hospitalization| L| O| R VENTRICULAR ASSIST DEVICE 2001.| TEMPORARY PACE MAKER 2001.