BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2335400 · Received November 4, 2011

    Report

    Report Number
    2017233-2011-00585
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    September 29, 2011
    Report Date
    November 4, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. A REVIEW OF THE FLUOROSCOPIC IMAGES STATED THE FOLLOWING: IMAGES CONFIRM THE USE OF THE GORE BALLOON WIRE (GBW) AND GORE BALLOON SHEATH (GBS) PRIOR TO STENT PLACEMENT. IMAGES SHOW THAT THE GBW BALLOON WAS NOT FULLY INFLATED AND THE GBS BALLOON WAS FULLY INFLATED IN THE SINGLE STILL ANGIOGRAM SHOWING GFRS COMPONENTS. THE CALCIUM BUILDUP NOTE IN THE EVENT DESCRIPTION WAS NOT EVIDENT ON AVAILABLE IMAGES. IMAGES CONFIRM THE USE OF THE ALTERNATIVE EMBOLIC PROTECTION DEVICE, AN EV3/COVIDIEN SPIDER FILTER, NOTED IN THE EVENT DESCRIPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS USING A GORE FLOW REVERSAL SYSTEM (GFRS). THE PHYSICIAN NOTED THAT THE GORE BALLOON WIRE LOST VOLUME BEFORE STENT PLACEMENT. THE PATIENT WAS NOTED TO HAVE MODERATE CALCIUM BUILDUP WHICH WAS THOUGHT TO HAVE CAUSED A SMALL HOLE IN THE BALLOON. A DISTAL FILTER WAS USED AND THE STENT WAS PLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    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 WLG380 8831822

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR