BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 104924 · Received July 9, 1997

    Report

    Report Number
    104924
    Event Type
    Death
    Date Received
    July 9, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 8, 1997
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FOR URGENT REDO OF AORTIC VALVE REPLACEMENT SECONDARY TO THROMBOSIS FORMATION. PT DIED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE Implant AORTIC VALVE LWQ CARBOMEDICS, INC. S500, TYPE A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death