BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPRA ANNULAR CARBOMEDICS VALVE

    MDR report key: 33110 · Received May 16, 1996

    Report

    Report Number
    33110
    Event Type
    Death
    Date Received
    May 16, 1996
    Date of Event
    April 13, 1996
    Report Date
    May 11, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED WITH 3 YR HISTORY OF AORTIC STENOSIS WITH PROGRESSIVELY WORSENING SHORTNESS OF BREATH. PRE-OPERATIVE STUDIES SHOWED ENLARGED LEFT ATRIUM AND LEFT VENTRICULAR HYPERTROPHY. TO OR ON 4/11/96 FOR REPLACEMENT OF AORTIC VALVE WITH MECHANICAL PROSTHESIS AND VALVE. POST OPERATIVELY HAD POOR RIGHT VENTRICULAR FUNCTION AND SEVERE CARDIAC DYSRHYTHMIA. SUGGESTED INFEROPOSTERIOR AND RIGHT VENTRICULAR MYOCARDIAL INFARCTION. PT DIED ON 4/13/96 OF MASSIVE MYOCARDIAL INFARCTION. CAUSE THOUGHT TO BE USER ERROR OR MIGRATION OR INTRA-OPERATIVE DISPLACEMENT OF SUTURED VALVE BY INTRA-OPERATIVE LEFT ATRIUM CATHETER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPRA ANNULAR CARBOMEDICS VALVE Implant PROSTHETIC CARDIAC VALVE LWQ CARBOMEDICS, INC. S500

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death