BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801252 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01084
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    February 4, 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

    CORRECTED DATA:IT WAS REPORTED THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED MODERATE-TO-SEVERE REGURGITATION; IT CONTINUES TO REMAIN IMPLANTED AND PERFORM ITS ESSENTIAL FUNCTION. THERE HAS BEEN NO EVIDENCE THAT THE PATIENT REQUIRED INTERVENTION.

    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. 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

    THICKENED LEAFLETS.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED SEVERE MITRAL REGURGITATION AT TWO (2) YEARS, SEVEN (7) MONTHS AFTER IMPLANT. DEVICE REMAINS IMPLANTED. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER INDICATING RIGID LEAFLETS SINCE IMPLANT AND PROGRESSIVE THICKENING OF THE LEAFLETS. ALSO, THE LEVEL OF REGURGITATION WAS MILD-TO-MODERATE. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC AND THAT SHE HAD INCREASING DYSPNEA ON EXERTION. THE PATIENT IS NOTED AS BEING OKAY AND DOES NOT REQUIRE INTERVENTION OF THE VALVE AT THIS TIME. HOWEVER, THE PATIENT MAY NEED TO HAVE A TAVI PROCEDURE IN THE FUTURE. SHE IS CURRENTLY BEING FOLLOWED BY THE OUT-PATIENT DEPARTMENT AND THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279499 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other