BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 1760653 · Received July 13, 2010

    Report

    Report Number
    2017233-2010-00328
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 12, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW AND IMAGING EVAL WERE PERFORMED. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE IMAGING EVAL REVEALED THAT PRIOR TO STENT DEPLOYMENT, THERE WAS ANTEGRADE BLOOD FLOW PAST THE INFLATED GORE BALLOON WIRE BALLOON IN THE EXTERNAL CAROTID ARTERY. THIS ANTEGRADE BLOOD FLOW INDICATES THAT THE EXTERNAL CAROTID ARTERY WAS NOT OCCLUDED. THE GORE BALLOON WIRE BALLOON ALSO APPEARED TO BE IN AN UNSTABLE POSITION WITHIN THE CAROTID ARTERY BIFURCATION PRIOR TO INITIATION OF STENT DEPLOYMENT. THE IMAGES CONFIRM DISLODGEMENT OF THE INFLATED GORE BALLOON WIRE BALLOON DURING STENT DEPLOYMENT. CONCLUSIONS: THE OUTER PORTION OF THE PRECISE STENT'S COAXIAL DELIVERY CATHETER MOVES BACK DURING STENT DEPLOYMENT. AS THE GORE BALLOON WIRE BALLOON WAS NOT FULLY APPOSED TO THE WALL OF THE EXTERNAL CAROTID ARTERY AND WAS IN AN UNSTABLE POSITION PRIOR TO STENT DEPLOYMENT, IT IS LIKELY THAT THE MOVEMENT OF THE STENT DELIVERY CATHETER DURING DEPLOYMENT DISLODGED THE GORE BALLOON WIRE BALLOON.

    Description of Event or Problem · 1

    DURING STENT DEPLOYMENT, THE GORE BALLOON WIRE WAS DISLODGED FROM ITS POSITION IN THE EXTERNAL CAROTID ARTERY BACK TOWARD THE COMMON CAROTID ARTERY AND OCCLUSION OF THE EXTERNAL CAROTID ARTERY WAS LOST. AFTER THE STENT DEPLOYMENT PORTION OF THE PROCEDURE WAS COMPLETE, AN ANGIOGRAPHY REVEALED THAT THE INFLATED GORE BALLOON WIRE HAD BEEN DISLODGED COMPLETELY OUT OF THE EXTERNAL CAROTID ARTERY AND INTO THE COMMON CAROTID ARTERY. THE GORE BALLOON WIRE WAS REPOSITIONED TO OCCLUDE THE EXTERNAL CAROTID ARTERY AND THE REMAINDER OF THE PROCEDURE WAS COMPLETED. THE PT DID NOT EXPERIENCE ANY NEUROLOGICAL COMPLICATIONS.

    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 7452508

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR CORDIS PRECISE STENT