BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2944538 · Received February 5, 2013

    Report

    Report Number
    2015691-2013-19199
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = X-RAY. DEVICE EVALUATION SUMMARY: AS RECEIVED, HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLETS 1, 2 AND 3. THE FREE MARGINS OF LEAFLETS 2 AND 3 EXHIBITED MINIMAL CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MOREOVER, MINIMAL TO MODERATE 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 1MM. HOST TISSUE WAS MINIMAL TO MODERATE AT THE STENT OUTFLOW AND INFLOW. WIREFORM WAS ALSO EXPOSED ON THE INFLOW ASPECT. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT. 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. NOTE THAT THIS PATIENT UNDERWENT AORTIC VALVE REPLACEMENT AT AGE (B)(6). THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE IS EXPECTED FOR RETURN, BUT HAS NOT YET BEEN RECEIVED. THEREFORE, THE NATURE OF THE REPORTED STENOSIS CANNOT BE EVALUATED OR CONFIRMED. NO ADDITIONAL INFORMAITON HAS YET BEEN PROVIDED BY THE HEALTHCARE PROVIDER REGARDING THE EVENT AND PATIENT MEDICAL HISTORY. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ADDITIONAL INFORMATION AND EVENT UPDATES WILL BE REPORTED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS BIOPROSTHETIC AROTIC VALVE WAS EXPLANTED FROM A (B)(6) MALE PATIENT, AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 YEARS DUE TO PROSTHETIC AORTIC STENOSIS. NO ADDITIONAL INFORMATION HAS YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49520 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000 3L1884

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| L| R