BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3163620 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20323
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = X-RAY. EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED; MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2, MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF LEAFLETS 1 AND 3. THE FREE MARGINS OF LEAFLETS 1 AND 2 EXHIBITED MINIMAL TO MODERATE CALCIFICATION, FREE MARGIN OF LEAFLET 3 EXHIBITED MINIMAL CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. ALSO, MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5MM. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. LEAFLET 1 HAD 2 TEARS, ONE AT COMMISSURE 1, TEAR MEASURED APPROX 5MM AND ONE TEAR AT COMMISSURE 2, TEAR MEASURED APPROX 11MM. LEAFLET 2 ALSO HAD A TEAR AT COMMISSURE 3, TEAR MEASURED APPROX 6MM. CALCIFICATION WAS ALSO VISIBLE AT THE REGIONS OF THE TEARS. THICKENED AND SWOLLEN TISSUE WAS ALSO OBSERVED ON LEAFLETS 2 AND 3. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT AN EDWARDS BIOPROSTHETIC VALVE WAS EXPLANTED AFTER A PERIOD OF ABOUT 10 YEARS DUE TO AORTIC STENOSIS AND INSUFFICIENCY. THE VALVE WAS REPLACED WITH ANOTHER EDWARDS PERICARDIAL BIOPROSTHETIC VALVE. PATIENT IS REPORTED AS STABLE POST SURGERY. INTRAOPERATIVE TEE WAS PERFORMED WHICH DEMONSTRATED IMPAIRMENT OF THE LEAFLET FUNCTION AS WELL AS INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264195 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R