BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3802740 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01095
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    July 13, 2011
    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 THE PATIENT EXPERIENCES MITRAL REGURGITATION. MITRAL REGURGITATION (MR) IN BIOPROSTHETIC HEART VALVES OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN SYSTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT ATRIUM. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. THERE IS INSUFFICIENT INFORMATION IN THIS CASE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED MILD-TO-MODERATE MITRAL REGURGITATION AT FIVE (5) MONTHS AFTER IMPLANT. AT ONE (1) YEAR AFTER IMPLANT, MITRAL REGURGITATION REMAINED MILD-TO-MODERATE. AT TWO (2) YEARS, ONE (1) MONTH, MITRAL REGURGITATION INCREASED TO SEVERE. THERE WERE ALSO ELEVATED GRADIENTS.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED MODERATE-TO-SEVERE MITRAL REGURGITATION AT FIVE (5) MONTHS AFTER IMPLANT. AT TWO (2) YEARS, ONE (1) MONTH, MITRAL REGURGITATION INCREASED TO SEVERE. THERE WERE ALSO ELEVATED GRADIENTS. DEVICE REMAINS IMPLANTED. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION INDICATING THE DEVICE HAS RIGID LEAFLETS SINCE IMPLANT. THE DEVICE CONTINUES TO REMAIN IMPLANTED AND THE PATIENT WILL BE FOLLOWED BY THE OUTPATIENT DEPARTMENT TO MONITOR THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280742 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other