BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2556403 · Received May 2, 2012

    Report

    Report Number
    2015691-2012-17390
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 2, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RECEIVED AND EVALUATED BY EDWARDS LABORATORY. THE VALVE EXHIBITED MODERATE TO HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLETS 2 AND 3. AT THE CUSP AREA OF LEAFLET 1, CALCIFICATION WAS MINIMAL. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MOREOVER, MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 6-7MM. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE BY 6MM. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MINIMAL AT STENT OUTFLOW. CONCLUSIONS: DEVICE EVALUATION CONFIRMS CALCIFICATION AND HOST TISSUE OVERGROWTH (PANNUS) AS THE PRIMARY CAUSES OF THE REPORTED STENOSIS. 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. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME. THEREFORE, IT IS LIKELY THAT PATIENT CONDITION AND MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE REPORTED STENOSIS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS BIOPROSTHETIC MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO CALCIFICATION STATING TWO LEAFLETS WERE ROCK HARD AND HOST TISSUE OVERGROWTH. PATIENT'S PREOPERATIVE DIAGNOSIS INDICATES, "MITRAL STENOSIS AND MITRAL PROSTHETIC PRIOR AORTIC VALVE REPLACEMENT, MITRAL VALVE REPLACEMENT, CORONARY BYPASS GRAFT X3, CORONARY ATHEROSCLEROTIC HEART DISEASE, SEVERE TRICUSPID REGURGITATION, HYPERLIPIDEMIA, HYPERTENSION, AV BLOCK TREATED WITH PERMANENT PACEMAKER, HYPOTHYROID." OPERATIVE PROCEDURE INDICATES, "...MITRAL VALVE WAS EXPOSED. THE VALVE HAD RATHER DENSE INGROWTH OF THE PATIENT'S ENDOCARDIAL TISSUE. THE SEWING RING OF THE VALVE WHICH WAS NOT VISIBLE. THIS TISSUE CONTINUED INTO THE INTROITUS OF THE VALVE. TWO OF THE LEAFLETS WERE HEAVILY CALCIFIED AND IMMOBILE, PRIMARILY THE 2 MORE ANTERIOR LEAFLETS. WE INCISED THE ENDOCARDIUM OVER THE SEWING RING CIRCUMFERENTIALLY AND REMOVED ALL SUTURES, AND THEN DISSECTED THE VALVE FROM SURROUNDING TISSUES." PATIENT ALSO HAD TRICUSPID VALVE REPAIR USING AN EDWARDS MC3 RING, DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R