BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 233777 · Received July 23, 1999

    Report

    Report Number
    1063481-1999-00023
    Event Type
    Injury
    Date Received
    July 23, 1999
    Date of Event
    April 1, 1999
    Report Date
    June 25, 1999
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXPLANT-AORTIC INSUFFICIENCY WITH TORN CUSP. 46 YEAR OLD MALE WITH MEDICAL HISTORY OF AORTIC STENOSIS/AORTIC INSUFFICIENCY, HYPERTENSION, PREVIOUS ENDOCARDITIS, AND VALVE REPLACEMENT USING 25MM AORTIC VALVE ON 08/21/1995. ON 04/01/99, PATIENT HAD HOMOGRAFT EXPLANTED DUE TO REGURGITATION AND A PERFORATION OF THE LEFT CORONARY CUSP. ACCORDING TO OPERATIVE REPORT, EXPLANTING SURGEON DESCRIBES 1CM IN DIAMETER PERFORATION NEAR THE ANNULUS OF THE LEFT CORONARY CUSP OF THE HOMOGRAFT WITH THE EDGES OF THE PERFORATION IRREGULAR, POSSIBLY INDICATING THAT THIS WAS "MOST LIKELY DUE TO A SECONDARY SEEDING OF HIS PREVIOUS INFECTION". AFTER EXCISING THE HEMOGRAFT AND DEBRIDING THE ANNULUS, THE SURGEON REPLACED IT WITH A NO.22 CRYOPRESERVED HEMOGRAFT. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE WITH A "DIFFICULT COAGULOPATHY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R