BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2884565 · Received December 23, 2012

    Report

    Report Number
    2015691-2012-18949
    Event Type
    Injury
    Date Received
    December 23, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. CONCLUSION: = DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. NO SERIAL NUMBER PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE DONE. IMPLANT DATE KNOWN ONLY AS 2004/2005. NO ADDITIONAL PATIENT HISTORY KNOWN. DEVICE WAS RECEIVED FOR PROCESSING AT OUR SWITZERLAND FACILITY AND WILL BE SHIPPED TO CALIFORNIA FOR EVALUATION. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. SUPPLEMENTAL REPORT TO BE SUBMITTED ONCE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VALVE AS RECEIVED SUPPORTS CUSTOMER REPORT OF REGURGITATION. MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1 AND HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2. THE FREE MARGIN OF LEAFLET 1 EXHIBITED MINIMAL TO MODERATE CALCIFICATION AND FREE MARGIN OF LEAFLET 2 EXHIBITED MODERATE TO HEAVY CALCIFICATION. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 3MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 7MM. HOST TISSUE WAS MODERATE AT THE STENT OUTFLOW AND MINIMAL AT THE STENT INFLOW. A TEAR WAS ALSO OBSERVED ON LEAFLET 3 AT COMMISSURE 3, TEAR MEASURED APPROX 6MM. THE X-RAY DEMONSTRATED CALCIFICATION. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: 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. BOTH CALCIFICATION AND HOST TISSUE OVERGROWTH CAN CAUSE REGURGITATION. IN THIS CASE, NO INFORMATION IS AVAILABLE REGARDING THE PATIENT HEALTH HISTORY OR PRESENT STATUS. THEREFORE, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE CALCIFICATION OF THIS DEVICE.

    Description of Event or Problem · 1

    EXPLANT AFTER 7-8 YEARS OF 6900 MITRAL VALVE DUE TO SEVERE REGURGITATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R