BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC VALVE & CONDUIT

    MDR report key: 13110441 · Received December 29, 2021

    Report

    Report Number
    3001451326-2021-00007
    Event Type
    Death
    Date Received
    December 29, 2021
    Date of Event
    October 19, 2021
    Report Date
    March 8, 2022
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THE PATIENT HAD AN EXPLANT OF A GRAFT IMPLANTED 15 YEARS AGO. PATIENT IS NOW DECEASED. DATE OF DEATH AND CAUSE ARE CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006342 AORTIC VALVE & CONDUIT HEART-VALVE, ALLOGRAFT MIE CRYOLIFE, INC. AV00

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Death