BEUDAMED
    FDA Adverse Event Other Summary report: N

    AORTIC VALVE AND CONDUIT

    MDR report key: 1669625 · Received April 16, 2010

    Report

    Report Number
    1063481-2010-00009
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    March 22, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SYNERGRAFT AORTIC VALVE AND CONDUIT WAS EXPLANTED EIGHT YEARS POST-OPERATIVELY. THE REASON FOR EXPLANT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC VALVE AND CONDUIT HEART VALVE ALLOGRAFT MIE CRYOLIFE, INC. AV00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other