BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCTS AORTIC ALLOGRAFT HEART VALVE CONDUIT

    MDR report key: 55009 · Received December 4, 1996

    Report

    Report Number
    2030400-1996-00001
    Event Type
    Other
    Date Received
    December 4, 1996
    Date of Event
    October 30, 1996
    Report Date
    December 4, 1996
    Manufacturer
    AMERICAN RED CROSS TISSUE
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLOGRAFT HEART VALVED CONDUIT EXPLANTED. SURGEON BELIEVES HE HAD TO EXPLANT THE ALLOGRAFT BECAUSE OF A PROBLEM WITH THE ALLOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTS AORTIC ALLOGRAFT HEART VALVE CONDUIT Implant ALLOGRAFT HEART VALVE MIE AMERICAN RED CROSS TISSUE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention SEE PRE-OP NOTE DATED 10-29-96.