BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2083527 · Received May 10, 2011

    Report

    Report Number
    2015691-2011-15501
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VALVE AS RECEIVED IS ATTACHED TO THE HOLDER. THE VALVE EXHIBITED DISRUPTION IN THE SEWING FABRIC AT LEAFLET 2 . A THREAD PROJECTED FROM THE SEWING FABRIC AT THE DESCRIBE AREA; IT MEASURED TO APPROXIMATELY TO 6MM. THE FABRIC IS UNRAVELED BY APPROXIMATELY 7MM AT THE FREE EDGE OF THE SEWING RING. AN EDWARDS ENGINEER OBSERVED THAT THE DISRUPTION IS AT THE MID OF THE SEWING FABRIC, AT THE FREE EDGE OF THE VALVE. IT WAS NOTED THAT THE SEWING LINE IS INTACT AT ASPECTS, THE INFLOW AND THE OUTFLOW ASPECT. THIS SUGGESTS THAT THE DISRUPTION IS MOST LIKELY DUE TO A CUT TO THE FABRIC. THE RETURNED DEVICE WAS EXAMINED VISUALLY WITH A LIGHT MICROSCOPE AND DIGITAL MICROSCOPE. EVALUATION RESULT: THE NATURE OF THE DISRUPTION SUGGESTS THAT IT WAS MOST LIKELY DUE TO A CUT TO THE FABRIC. CONCLUSION: THE NATURE OF THE DISRUPTION SUGGESTS THAT IT WAS MOST LIKELY DUE TO A CUT TO THE FABRIC. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IT IS UNKNOWN WHEN THE DISRUPTION OCCURED, HOWEVER, BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A TEAR IN THE CLOTH AROUND THE SEWING RING OF A 3300TFX23MM WAS DISCOVERED. THE TEAR WAS NOTICED IMMEDIATELY AFTER THE VALVE WAS WASHED; BEFORE ANY SUTURES WERE PLACED. THE SURGEON DECIDED NOT TO IMPLANT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-11B0683

    Patients

    Seq Age Sex Outcome Treatment
    1