BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 228053 · Received May 14, 1999

    Report

    Report Number
    1063481-1999-00018
    Event Type
    Other
    Date Received
    May 14, 1999
    Date of Event
    May 12, 1999
    Report Date
    May 14, 1999
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON THAWING OF TISSUE, SITE RELATED THAT SURGEON COULD NOT INSERT A 19MM HEGAR DILATOR THROUGH THE VALVE ANNULUS. SURGEON FELT THE VALVE WAS SMALLER THAN DOCUMENTED AND WAS NOT SUITABLE FOR THE RECIPIENT. SURGEON THAWED AND IMPLANTED A 21MM VALVE.

    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 NA Other| R