BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3971779 · Received July 31, 2014

    Report

    Report Number
    2015691-2014-01752
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT VALVE HAS NOT BEEN RETURNED (REMAINS IMPLANTED) AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE HEALTHCARE PROVIDER DESPITE MULTIPLE FOLLOW UPS ATTEMPTS BY EDWARDS. THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. A SUPPLEMENTARY MDR WILL BE SUBMITTED IN THE EVENT NEW INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTED MITRAL BIOPROSTHETIC VALVE NOW REQUIRES INTERVENTION DUE TO ONE RESTRICTED LEAFLET, AFTER AN IMPLANT DURATION OF APPROXIMATELY EIGHTEEN (18) MONTHS. THE PATIENT IS PLANNED TO UNDERGO AN IMPLANT OF A TRANSCATHETER HEART VALVE INSIDE OF THE SUBJECT VALVE (VALVE IN VALVE), BUT INTERVENTION HAS NOT YET BEEN PERFORMED. NO ADDITIONAL INFORMATION HAS YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448946 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L