BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2151767 · Received July 6, 2011

    Report

    Report Number
    2015691-2011-15832
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVE DATA REPORTED IN INITIAL MDR. EVALUATION: X-RAY. EVALUATION SUMMARY: AS RECEIVED, THE VALVE EXHIBITS HEAVY CALCIFICATION IN THE CUSP AREA AND THE FREE MARGINS OF ALL THREE LEAFLETS. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 4-5MM. HOST TISSUE IS MODERATE TO HEAVY AT THE STENT OUTFLOW. AS RECEIVED, APPROXIMATELY TWO THIRDS OF THE SEWING RING IS CUT OFF, WHICH EXPOSED THE WIREFORM, MOST LIKELY DUE TO EXPLANT. THE X-RAY DEMONSTRATES CALCIFICATION, AND WIREFORM TO BAND SEPARATION, MOST LIKELY DUE TO EXPLANT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE OPERATIVE REPORT AND PATIENT INFORMATION, HOWEVER, NO INFORMATION HAS BEEN RECEIVED. WITHOUT ADDITIONAL INFORMATION REGARDING THE PATIENT HISTORY, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED CALCIFICATION OF THIS DEVICE. 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.

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD (B)(4): DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION (B)(4): DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE OPERATIVE REPORT AND PATIENT INFORMATION, HOWEVER, NO INFORMATION HAS BEEN RECEIVED. WITHOUT ADDITIONAL INFORMATION REGARDING THE PATIENT HISTORY, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED CALCIFICATION OF THIS DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, THE SALES REPRESENTATIVE RECEIVED A TEXT MESSAGE FROM THE SURGEON ABOUT AN EDWARDS VALVE EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS (2005). THE SURGEON ALSO COMMENTED THE PATIENT HAS A 128MMHG PEAK GRADIENT. THE SURGEON INDICATED THE VALVE WAS HEAVILY CALCIFIED AFTER SUCH A SHORT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R