BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 167175 · Received May 12, 1998

    Report

    Report Number
    1039618-1998-00023
    Event Type
    Injury
    Date Received
    May 12, 1998
    Date of Event
    June 9, 1997
    Report Date
    April 13, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 56 YR OLD MALE WITH MED HISTORY OF AORTIC STENOSIS AND HYPERTENSION UNDERWENT AN AORTIC VALVE REPLACEMENT FREEHAND USING A 24MM AORTIC HOMOGRAFT ON 12/01/1994. EARLY 1996 PT WAS SUCCESSFULLY TREATED FOR ENDOCARDITIS (SUBACUTE BACTERIAL ENDOCARDITIS), BUT WAS LEFT WITH RESIDUAL AORTIC INSUFFICIENCY. ON 06/09/1997, VALVE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY, CALCIFICATION, CUSP DEGENERATION, AND PERFORATION OF VALVE. THE VALVE WAS REPLACED WITH ANOTHER HOMOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE Implant AORTIC VALVE AND CONDUIT MIE CRYOLIFE, INC. NA 18197

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R