BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 171929 · Received June 8, 1998

    Report

    Report Number
    1039618-1998-00024
    Event Type
    Injury
    Date Received
    June 8, 1998
    Date of Event
    September 9, 1996
    Report Date
    April 24, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    49 YEAR OLD FEMALE WITH MEDICAL HISTORY OF MITRAL INSUFFICIENCY, RHEUMATIC HEART DISEASE, AND PULMONARY HYPERTENSION S/P MITRAL VALVE BALLOON VALVULOPLASTY UNDERWENT A MITRAL VALVE REPLACEMENT USING A 28MM MITRAL HOMOGRAFT ON 3/25/1996. ON 9/9/1996, PT REQUIRED REOPERATION DUE TO MITRAL REGURGITATION. THE PT HAD HER MITRAL VALVE MEDIAL COMMISSURE AND TRICUSPID VALVE REPAIRED. THE SITE HAS NOT ASSESSED THE RELATION OF THE EVENT TO THE HOMOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE Implant MITRAL VALVE MIE CRYOLIFE, INC. MITRAL VALVE 25255

    Patients

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