BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN

    MDR report key: 2121785 · Received June 10, 2011

    Report

    Report Number
    2121785
    Event Type
    Death
    Date Received
    June 10, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 1, 2011
    Manufacturer
    SORIN GROUP
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 - PT HAD SURGERY RE-DO AORTIC VALVE REPLACEMENT DUE TO EARLY FAILURE OF A 19 MM MITROFLOW BIOPROSTHESIS APPROX 2 1/2 YEARS AGO. SHE HAD EVIDENCE OF INCREASED VELOCITIES ACROSS THE BIOPROSTHETIC AORTIC VALVE AND CAME TO THE HOSPITAL IN CONGESTIVE HEART FAILURE. PT WAS RECOVERING WELL UNTIL (B)(6) WHEN SHE ARRESTED AND EXPIRED AFTER FAILED RESUSITATION. PROVISIONAL AUTOPSY RESULTS INDICATE CARDIOMEGALY, (CONGESTIVE HEART FAILURE) AND BILATERAL PULMONARY EDEMA. PROSTHETIC VALVE ANNULUS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN 19 MM MITROFLOW BIOPROSTHESIS LWR SORIN GROUP 19 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R