BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 1662696 · Received April 8, 2010

    Report

    Report Number
    2017233-2010-00151
    Event Type
    Injury
    Date Received
    April 8, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 8, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS WAS CONDUCTED. RESULT - A REVIEW OF THE MFG RECORDS VERIFIED THE LOT MET ALL PRE-RELEASE SPECS. THE DEVICE WAS DISCARDED BY THE FACILITY AND THEREFORE AN ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A (B) (6) MALE PT UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY FOR A LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS. A GORE FLOW REVERSAL SYSTEM WAS USED FOR EMBOLIC PROTECTION. THE GORE BALLOON WIRE (GBW) BALLOON AND THE GORE BALLOON SHEATH (GBS) BALLOON WERE INFLATED AND FLOW REVERSAL WAS CONFIRMED, ALTHOUGH IT WAS NOTED TO BE SLOW. WHILE CONFIRMING FLOW REVERSAL, THE GBW BALLOON APPEARED TO BE LOSING VOLUME. THE PHYSICIAN RE-TIGHTENED THE REMOVABLE HUB AND RE-INFLATED THE BALLOON TWICE BEFORE THE BALLOON REMAINED INFLATED. THE LESION WAS PRE-DILATED UNDER ACTIVE ASPIRATION. AT THE STENT WAS POSITIONED ACROSS THE LESION, THE PHYSICIAN NOTED STAGNANT FLOW REVERSAL. AIR WAS ENTRAINED IN THE GBS HUB AND BOTH HEMOSTASIS VALVES WERE OPENED TO RELEASE THE AIR; HOWEVER, THERE WAS NO BACK BLEEDING THROUGH THE VALVES. THE UNDEPLOYED STENT MAY HAVE OCCLUDED THE ICA. THE PT STARTED YAWNING. THE PHYSICIAN QUICKLY COMPLETED THE PROCEDURE. AT CASE COMPLETION, THE PT COULD NOT MOVE HIS RIGHT HAND OR FOOT. FIFTEEN - THIRY MINUTES LATER, THE PT RESUMED ALL NEUROLOGICAL AND MOTOR FUNCTION PRIOR TO ENTERING THE RECOVERY ROOM.

    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 7383053

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other