BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4233329 · Received November 6, 2014

    Report

    Report Number
    2015691-2014-02626
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, HORIZONTAL CREASES WERE OBSERVED IN THE CUSP AREAS OF TWO LEAFLETS. CREASES WERE ALSO OBSERVED ON A LEAFLET NEAR THE COMMISSURE. ONE LEAFLET EXHIBITED A CUT NEAR THE SEWING RING WHICH PENETRATED THROUGH THE ENTIRE THICKNESS OF THE LEAFLET. THESE DAMAGES ARE MOST LIKELY DUE TO IMPLANT OR EXPLANT WITH NO VISIBLE DAMAGE TO THE WIREFORM, VIA X-RAY. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER REPORT OF REGURGITATION COULD NOT BE CONFIRMED BY VISUAL OBSERVATION. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING RE-OPERATION IN THE IMMEDIATE POST-OPERATIVE PERIOD IS DUE TO PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AT IMPLANT DUE TO SEVERE MITRAL REGURGITATION. AS REPORTED, THE SURGEON IMPLANTED THE 31MM VALVE AND THE PATIENT WAS REMOVED FROM CARDIOPULMONARY BYPASS (CPB). UPON ASSESMENT, THE VALVE DEMONSTRATED "WIDE OPEN MITRAL INSUFFICIENCY." THE PATIENT WAS PLACED BACK ON CPB AND THE DEVICE WAS REMOVED. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713854 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R