BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 6517150 · Received April 24, 2017

    Report

    Report Number
    2015691-2017-01095
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    February 15, 2017
    Report Date
    March 30, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS, MODEL# 3300TFX, PMA# P860057/S042. ADDITIONAL MANUFACTURER NARRATIVE: HIGH GRADIENT CAN BE A RESULT OF POSSIBLE VALVE RELATED AND/OR NON-VALVE RELATED ISSUES. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. AT THIS TIME, THE PATIENT CONTINUES TO BE MONITORED FOR THE INCREASING GRADIENT. EDWARDS LIFESCIENCES IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION AND THE ROOT CAUSE FOR THE REPORTED HIGH GRADIENT CANNOT BE DETERMINED AT THIS TIME. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THE CONDITION OF THE SUBJECT DEVICE. BIOLOGICAL VALVE AT AORTIC OSTIUM, FIBROTIC EDGES OF ONE LEAFLET (IN THE POSITION OF RIGHT CORONARY LEAFLET) PRESERVED MOBILITY. SMALL CENTRAL WAVE OF AORTIC VALVE REGURGITATION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THREE (3) YEARS, TWENTY-FOUR (24) DAYS POST-IMPLANTATION, THIS 19MM BIOPROSTHETIC HEART VALVE IS EXHIBITING A HIGH GRADIENT, AS OBSERVED ON ECHOCARDIOGRAM. IT WAS LEARNED THAT IN THE 2 YEAR FOLLOW-UP VISIT, THE PATIENT HAD MAX GRADIENT OF 55 MMHG AND MEAN GRADIENT OF 35 MMHG. IN THE 3 YEAR FOLLOW-UP VISIT, THE PATIENT HAD MAX GRADIENT OF 100-118 MMHG AND MEAN GRADIENT OF 55-64 MMHG. THE REASON FOR THE GRADIENT IS UNKNOWN. THE VALVE REMAINS IMPLANTED, NO MEDICATION WAS GIVEN, AND THE OUTCOME IS NOTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298747 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR