BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4201250 · Received October 27, 2014

    Report

    Report Number
    2015691-2014-02512
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 26, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY THE ADAPTER WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, A BLUE FRAGMENT, APPROX 4MM IN LENGTH, APPEARED SIMILAR TO THE MATERIAL OF THE BLUE ADAPTER. THE ADAPTER WAS FOUND TO HAVE DAMAGE NEAR THE ADAPTER ATTACHMENT, THAT WAS APPROX 3MM IN LENGTH WITH A CUT THAT WAS APPROX 2MM IN LENGTH. THE CUT HAD SHARP, STRAIGHT EDGES AND EXTENDED FROM THE INSIDE OF THE ADAPTER ATTACHMENT TOWARDS THE HANDLE ATTACHMENT SITE. ADAPTER THREADS ALSO APPEARED TO HAVE DAMAGE AT THE HANDLE ATTACHMENT SITE. THERE WERE NO VISIBLE INCONSISTENCIES OBSERVED ON THE HOLDER. ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER REPORT OF BLUE FRAGMENT WAS CONFIRMED. FURTHER INSPECTION CONDUCTED BY RESEARCH AND DEVELOPMENT DETERMINED THE BLUE FRAGMENT WAS CUT FROM THE INITIAL THREAD OF THE BLUE ADAPTER. THERE ARE CUTTING STRIATIONS ALONG THE LENGTH OF THE CUT SURFACE AND THIN REMNANT BURRS AT THE CUT EDGES. HOWEVER, IT CANNOT BE DETERMINED IF THE CUT WAS MADE BY THE HANDLE DURING THE HANDLE ATTACHMENT, OR IF IT WAS CUT BY ANOTHER METHOD (BLADE). 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 BLUE FRAGMENT WAS FOUND ON A LEAFLET OF THIS PERICARDIAL VALVE. THROUGH INVESTIGATION, IT WAS LEARNED THAT THE BLUE FRAGMENT WAS OBSERVED ON THE LEAFLET AFTER SLIDING THE VALVE DOWN INTO THE PATIENT¿S ANNULUS AND REMOVING THE HOLDER. THE SURGEON COMMENTED THAT THERE WAS A POSSIBILITY THE SURGICAL KNIFE MIGHT HAVE SCRAPED THE BLUE ADAPTOR. THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE AND THE VALE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS TRANSFERRED THE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682311 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR