BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2880800 · Received December 20, 2012

    Report

    Report Number
    2015691-2012-18907
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DEVICE WAS RECEIVED BY OUR FACILITY IN (B)(4) FOR DECONTAMINATION AND WILL BE EVALUATED ONCE IT IS RECEIVED BY OUR FACILITY IN THE U.S.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CUSTOMER REPORT OF STENOSIS WAS CONFIRMED. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 10MM. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 6MM. HOST TISSUE WAS MODERATE TO HEAVY AT BOTH THE STENT INFLOW AND OUTFLOW. HOST TISSUE FUSED LEAFLETS 2 AND 3 AT COMMISSURE 3 BY 6MM ON THE INFLOW ASPECT. HOST TISSUE FUSED LEAFLETS 1 AND 3 AT COMMISSURE 1 BY 2MM AND LEAFLETS 1 AND 2 AT COMMISSURE 2 BY 2MM ON THE OUTFLOW ASPECT. MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE FREE MARGIN AREAS OF LEAFLETS 1 AND 2. SEWING RING WAS ALSO EXPOSED, A PIECE OF SEWING RING APPEARED TO BE CUT NEAR COMMISSURE 1 AND NOT RETURNED WITH THE VALVE. THE X-RAY DEMONSTRATED CALCIFICATION. ADDITIONAL MANUFACTURER NARRATIVE: EVALUATION CONFIRMED CUSTOMER REPORT OF STENOSIS. STENOSIS MOST LIKELY WAS DUE TO HOST TISSUE OVERGROWTH AND 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. 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.

    Description of Event or Problem · 1

    REPORTEDLY, A MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS, 8 MONTHS DUE TO STENOSIS. CUSTOMER REPORTED: STENOTIC EDWARDS MAGNA VALVE. PT EXHIBITED SHORTNESS OF BREATH FOR SEVERAL YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX 07A008

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R