BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUMAN HEART ALLOGRAFT

    MDR report key: 4902261 · Received July 9, 2015

    Report

    Report Number
    1063481-2015-00109
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    December 1, 2005
    Report Date
    July 7, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 FDA MAUDE EVENT REPORT MW5042437, AN UNSPECIFIED "HEART VALVE, MORE THAN MINIMALY MANIPULATED ALLOGRAFT, ENGINEERED BICUSPID HEART VALVE" WAS IMPLANTED INTO A PATIENT WITH A REPORTED DEATH. IT IS NOT CLEAR FROM THE REPORT WHAT PRODUCT WAS UTILZED IN THE CASE, ONLY THAT IT WAS AN "ENGINEERED VALVE FIRST OF ITS KIND BY CRYOLIFE, INC."PLEASE SEE THE ATTACHED MAUDE EVENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444971 HUMAN HEART ALLOGRAFT MIE CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death