BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3803304 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01107
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS PATIENT EXPERIENCES AORTIC 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 REPORTED WAS NOT RETURNED TO MANUFACTURER AS IT REMAINS IMPLANTED. WITHOUT EVALUATION OF THE DEVICE THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES AORTIC REGURGITATION IS MODERATE AND MITRAL REGURGITATION IS TRIVIAL BASED ON A DIFFERENT GRADING SCALE. BOTH DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    ON ECHO FOUR (4) MONTHS POST-OP, THE AORTIC VALVE EXHIBITED SEVERE AORTIC REGURGITATION THAT WAS NOTED AS PARAVALVULAR LEAK. THE MITRAL VALVE HAD MILD MITRAL REGURGITATION. THE DEVICES REMAIN IMPLANTED. THROUGH INVESTIGATION, THE INFORMATION PROVIDED INDICATES THE PATIENT HAS NOT REQUIRED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280957 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other