BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801264 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01083
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    August 7, 2013
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS PATIENT EXPERIENCES REGURGITATION. 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 REMAINS IMPLANTED IN THE PATIENT. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION OF A MITRAL BIOPROSTHETIC VALVE THAT HAS EXHIBITED SEVERE MITRAL REGURGITATION ONE (1) MONTH POST IMPLANT AND AGAIN TWO (2) MONTHS POST IMPLANT. THE DEVICE REMAINS IMPLANTED. NO SERIOUS ADVERSE EVENT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED INDICATES REGURGITATION WAS INACCURATELY REPORTED AS SEVERE. PATIENT PRESENTS WITH MILD TO MODERATE PARAVALCULAR LEAKAGE AT 1 MONTH F/U AND MODERATE PARAVALVULAR WITH MILD VALVULAR REGURGITATION. DEVICE REMAINS IMPLANTED. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278685 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other