BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1986831 · Received February 11, 2011

    Report

    Report Number
    2015691-2011-14795
    Event Type
    Death
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. RETURNED DEVICE EVALUATION INDICATES MODERATE TO HEAVY CALCIFICATION RESTRICTING LEAFLET MOBILITY, WHICH 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. THE INVESTIGATION INDICATES NO QUALITY DEFICIENCIES DETECTED DURING THE MANUFACTURE OF THE SUBJECT DEVICE. WITHOUT ADDITIONAL INFORMATION FROM THE HOSPITAL, NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    EVALUATION - MODERATE TO HEAVY CALCIFICATION IS DETECTED IN THE CUSP AREA OF ALL THREE LEAFLETS. AT THE FREE MARGINS, CALCIFICATION IS MODERATE IN LEAFLET 1 AND HEAVY IN LEAFLET 3. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 9MM. IT FUSED THE FREE MARGINS OF LEAFLET 1 AND 3 AT COMMISSURE 1 BY APPROXIMATELY 4-5MM. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE BY 3MM. HOST TISSUE IS MINIMAL TO MODERATE AT THE STENT INFLOW AND HEAVY AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATES CALCIFICATION. THE VALVE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE. METHOD = X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW UP WITH THE HOSPITAL, IT WAS LEARNED THAT THE PATIENT EXPIRED 1 DAY POST-OPERATIVELY DUE TO MULTISYSTEM ORGAN FAILURE. THE TEE, OPERATIVE REPORT, DISCHARGE SUMMARY, AND/OR AUTOPSY REPORT WERE REQUESTED BUT HAVE NOT BEEN PROVIDED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME. THE DEVICE HISTORY RECORD REVIEW IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    IT WAS LEARNED THROUGH FOLLOW UP WITH HOSPITAL THAT THE PATIENT EXPIRED 1 DAY POST OPERATION, DUE TO MULTISYSTEM ORGAN FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SALES REPRESENTATIVE THAT A DEVICE HAD BEEN EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS AND 6 MONTHS (90.13 MONTHS) DUE TO "CALCIFICATION OVERGROWTH AND TWO OF THE LEAFLETS NOT MOVING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 3B0357

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| R