BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4140197 · Received October 3, 2014

    Report

    Report Number
    2015691-2014-02313
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE HAS NOT YET BEEN RETURNED TO EDWARDS FOR EVALUATION, THUS THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED 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. THERE WAS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    X-RAY. CUSTOMER REPORT OF CALCIFICATION WAS CONFIRMED. HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE LEAFLETS. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS LED TO STENOSIS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 9MM. HOST TISSUE WAS MINIMAL AT BOTH THE STENT INFLOW AND STENT OUTFLOW. HEMATOMA WAS OBSERVED ON LEAFLETS 2 AND 3 ON THE OUTFLOW ASPECT. THE X-RAY DEMONSTRATED CALCIFICATION, COMMISSURE 1 WIREFORM DISTORTED. APPROX 1/3 OF THE SEWING RING WAS CUT. COMMISSURE 1 WIREFORM WAS EXPOSED ON THE OUTFLOW ASPECT AND WIREFORM NEAR LEAFLET 2 WAS EXPOSED ON THE INFLOW ASPECT. THESE DAMAGES ARE MOST LIKELY DUE TO EXPLANT OR IMPLANT.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT AN AORTIC BIOPROSTHETIC VALVE MODEL 3000-21MM WAS EXPLANTED DUE TO CALCIFICATION AFTER AN IMPLANT DURATION OF APPROXIMATELY TEN (10) YEARS. ANOTHER EDWARDS PERICARDIAL VALVE MODEL WAS IMPLANTED AS A REPLACEMENT. THERE WERE NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620549 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R