BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4181120 · Received October 17, 2014

    Report

    Report Number
    2015691-2014-02440
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED TO EDWARDS AND AN EVALUATION OF THE PRODUCT IS CURRENTLY PENDING ITS ARRIVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, A GREEN TINT WAS OBSERVED ON ALL THREE (3) LEAFLETS ON THE INFLOW ASPECT. ONE LEAFLET EXHIBITED A CUT AREA THAT WAS NOT RETURNED WITH THE DEVICE. MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE (3) LEAFLETS AND WAS CONFIRMED VIA X-RAY. MINIMAL TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT, AT THE OUTFLOW ASPECT, INTO THE ORIFICE, AT THE STENT INFLOW AND AT THE STENT OUTFLOW. HEMATOMA WAS OBSERVED ON ALL THREE (3) LEAFLETS ON BOTH INFLOW AND OUTFLOW ASPECTS. INCIDENTAL FINDINGS: THE COMMISSURAL WIREFORM WAS DISTORTED. APPROXIMATELY 90% OF SEWING RING WAS CUT AND WIREFORM WAS EXPOSED ON THE INFLOW ASPECT AND THE OUTFLOW ASPECT NEAR A LEAFLET. THESE DAMAGES ARE LIKELY DUE TO EXPLANT OR IMPLANT. (B)(4). CUSTOMER REPORT OF STENOSIS COULD BE CONFIRMED AS CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A (B)(6) MALE UNDERWENT AN AORTIC VALVE EXPLANT AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, THREE (3) MONTHS DUE TO STENOSIS, SECONDARY TO CALCIFICATION. THIS WAS REPLACED WITH A 21 MM PERICARDIAL BIOPROSTHESIS. THERE WAS A "PECULIAR" LEAK REVEALED VIA ECHO WHICH REQUIRED ADDITIONAL SUTURES TO BE PLACED. REPEAT ECHO NO LONGER SHOWED A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662375 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R