BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3003004 · Received March 13, 2013

    Report

    Report Number
    2015691-2013-19542
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1 AND 2, MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. THE FREE MARGINS OF LEAFLETS 1 AND 3 EXHIBITED MODERATE CALCIFICATION, FREE MARGIN OF LEAFLET 2 EXHIBITED MODERATE TO HEAVY CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 6MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 3MM. HOST TISSUE WAS MODERATE AT THE STENT INFLOW AND OUTFLOW. LEAFLET 1 HAD CUT AREA OF 10MM X 3MM. CUT SECTION WAS NOT RETURNED WITH THE VALVE. LEAFLET 3 HAD A TEAR AT COMMISSURE 1 (3MM) AND AT FREE MARGIN (6MM),CALCIFICATION WAS ALSO OBSERVED AT THE REGION OF THE TEARS. WIREFORM WAS ALSO EXPOSED BETWEEN COMMISSURE 1 AND 3 ON THE INFLOW ASPECT, WHILE COMMISSURE 1 ALSO APPEARED BENT OUTWARD; POSSIBLY RELATED TO THE EXPLANT PROCEDURE. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT, IN ADDITION TO MODERATE HOST TISSUE OVERGROWTH (PANNUS). 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 IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SALES THAT AN EDWARDS AORTIC BIOPROSTHETIC VALVE MODEL 3000TFX WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 66 MONTHS DUE TO SEVERE AORTIC STENOSIS. OPERATIVE REPORT INDICATES: " THERE WAS A SMALL AMOUNT OF VEGETATIVE CALCIFICATION ASSOCIATED WITH THE COMMISSURES AT THE STRUTS, ALTHOUGH WITHOUT ACTUAL FUSION; THERE WAS NO EVIDENCE OF INFECTION. THE LEAFLETS WERE MILDLY DISCOLORED, BUT WERE VARIABLY BUT SEVERELY RESTRICTED IN MOVEMENT, PARTLY DUE TO CALCIFICATION AND ALSO THICKENING AND FIBROSIS OF THE LEAFLET. THIS PRODUCED SIGNIFICANT LEAFLETS OBSTRUCTION AND VALVE STENOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104933 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R