BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 1966845 · Received January 14, 2011

    Report

    Report Number
    2017233-2011-00018
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. CASE FILMS WERE EVALUATED. RESULTS - AN ENGINEERING ANALYSIS OF THE RETURNED DEVICE FOUND THE FUNCTIONAL ASPECTS OF BALLOON INFLATION AND ABILITY TO STAY INFLATED MET APPROVED SPECIFICATIONS. BASED ON THE ENGINEERING ANALYSIS, THE REASON FOR THE GORE BALLOON WIRE'S INABILITY TO MAINTAIN POSITION IN THE EXTERNAL CAROTID ARTERY (ECA) CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE CASE FILMS PROVIDED CANNOT CONFIRM THE INITIAL ESTABLISHMENT OF FLOW REVERSAL, GBW DISLODGEMENT BY THE PRE OR POST-DILATATION BALLOONS, OR GBW REMOVAL WITH THE POST-DILATATION BALLOON.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A GORE FLOW REVERSAL SYSTEM WAS USED FOR EMBOLIC PROTECTION IN A CAROTID ARTERY STENTING AND ANGIOPLASTY PROCEDURE. THE GORE BALLOON WIRE (GBW) WAS PLACED AND INFLATED IN THE EXTERNAL CAROTID ARTERY (ECA) CLOSE TO THE CAROTID BIFURCATION. FLOW REVERSAL WAS CONFIRMED AND THE LESION WAS PRE-DILATED. AS THE PRE-DILATION BALLOON WAS RETRACTED, THE GBW WAS PULLED FROM THE ECA INTO THE CAROTID BIFURCATION. THE GBW BALLOON WAS REPOSITIONED MORE DISTAL IN THE ECA. THE LESION WAS STENTED AND POST-DILATED. AS THE POST-DILATATION BALLOON WAS RETRACTED, THE GBW WAS PULLED INTO THE CAROTID BIFURCATION. THE POST-DILATATION BALLOON AND GBW WERE REMOVED TOGETHER AND THE PROCEDURE WAS CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE FLOW REVERSAL SYSTEM NTE / TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE W.L. GORE & ASSOCIATES, INC WLG380 8177332

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR