BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4221981 · Received November 3, 2014

    Report

    Report Number
    2015691-2014-02595
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE EVALUATION CONFIRMED THE REPORTED STENOSIS AS SECONDARY TO CALCIFICATION. 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO CAPA IS APPLICABLE; HOWEVER, EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: AS RECEIVED, HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE LEAFLETS. THE FREE MARGIN OF LEAFLETS 1 AND 3 EXHIBITED MINIMAL CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 3MM. HOST TISSUE WAS MODERATE AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. HEMATOMA WAS OBSERVED ON ALL THREE LEAFLETS ON THE OUTFLOW ASPECT. INCIDENTAL FINDINGS: THE X-RAY DEMONSTRATED CALCIFICATION, COMMISSURE 3 WIREFORM DISTORTED. APPROX 90% OF THE SEWING RING WAS CUT AND APPROX 90% OF THE WIREFORM CIRCUMFERENCE 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 THIS 23MM BIOPROSTHETIC VALVE WAS EXPLANTED DUE TO STENOSIS OF THE BIOPROSTHESIS AFTER AN IMPLANT DURATION OF SIX (6) YEARS, TWO (2) MONTHS. PATENT WAS IMPLANTED WITH A 21MM BIOPROSTHESIS. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701261 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R