BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 3888313 · Received May 29, 2014

    Report

    Report Number
    3888313
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 5, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CORMATRIX PATCH WAS USED DURING MITRAL VALVE REPLACEMENT. THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL AND TAKEN TO THE OR FOR SEVERE MITRAL REGURGITATION. DILATATION OF THE PATCH WAS NOTED. IT WAS RESECTED AND RESEWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317222 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET, INTRACARDIAC DXZ CORMATRIX CARDIOVASCULAR, INC. * M13A1004

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR