BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801209 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01082
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    July 10, 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

    HIGH GRADIENTS. ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS PATIENT EXPERIENCES REGURGITATION AND HIGH GRADIENTS. 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

    ADDITIONAL MANUFACTURER NARRATIVE - ADDITIONAL INFORMATION RECEIVED INDICATES REGURGITATION IS PARAVALVULAR IN NATURE. REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS, INCLUDING TECHNIQUE AND PATIENT RELATED FACTORS. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION OF A MITAL BIOPROSTHETIC VALVE THAT NOW PRESENTS WITH HIGH GRADIENT THAT EXCEEDS EXPECTED RANGE AND SEVERE MITRAL REGURGITATION. THE VALVE REMAINS IMPLANTED. THERE ARE NO ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES REGURGITATION IS OF PARIVALVULAR ORIGIN. LEVEL OF REGURGITATION REMAINS SEVERE AND DEVICE REMAINS IMPLANTED AND PATIENT IS SYMPTOMATIC WITH NOT SPECIFIC SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279408 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other