BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2121285 · Received May 5, 2011

    Report

    Report Number
    2017233-2011-00222
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 4, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE MFG HISTORY RECORD REVIEW. CASE ANGIOGRAPH REVIEW. RESULTS - LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. OVERINFLATION OF GORE BALLOON SHEATH BALLOON. THE GORE BALLOON SHEATH BALLOON APPEARS TO BE GROSSLY OVERINFLATED. OVERINFLATION OF THE MAGNITUDE SHOWN IN THE IMAGES WOULD LIKELY OCCLUDE THE GORE BALLOON SHEATH WORKING LUMEN. THE RESISTANCE NOTED DURING THE PASSAGE OF THE GUIDEWIRE THROUGH THE SHEATH WAS LIKELY DUE TO THE GUIDEWIRE PUNCTURING THE GORE BALLOON SHEATH BALLOON.

    Description of Event or Problem · 1

    A GORE FLOW REVERSAL SYSTEM WAS USED FOR EMBOLIC PROTECTION DURING A CAROTID ARTERY STENTING AND ANGIOPLASTY PROCEDURE. ALL COMPONENTS OF THE SYSTEM WERE PLACED AND FLOW REVERSAL WAS ESTABLISHED. RESISTANCE WAS FELT AS A GUIDEWIRE WAS ADVANCED PAST THE GORE BALLOON SHEATH BALLOON, AND SHORTLY AFTER IT WAS NOTED THAT THE BALLOON HAD LOST WALL APPOSITION. THE BALLOON COULD NOT BE RE-INFLATED. THE PHYSICIAN LEFT THE GORE BALLOON SHEATH IN PLACE IN THE COMMON CAROTID ARTERY, AND ALSO LEFT THE GORE BALLOON WIRE BALLOON INFLATED AND IN PLACE IN THE EXTERNAL CAROTID ARTERY. HE THEN INSERTED A DISTAL EMBOLIC FILTER DEVICE AND COMPLETED 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 8673757

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR