BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2729954 · Received August 30, 2012

    Report

    Report Number
    2017233-2012-00585
    Event Type
    Injury
    Date Received
    August 30, 2012
    Date of Event
    May 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE DEVICE WAS DISCARDED AT THE FACILITY; THEREFORE, AN ENGINEERING ANALYSIS CANNOT BE PERFORMED. CASE IMAGES WERE RETURNED FOR EVALUATION. SIGNIFICANT VESSEL TORTUOSITY WAS OBSERVED IN THE DISTAL INTERNAL CAROTID ARTERY AND PROXIMAL COMMON CAROTID ARTERY. PER THE INSTRUCTIONS FOR USE, THE GORE FLOW REVERSAL SYSTEM IS CONTRAINDICATED IN ANATOMIES PRESENTING WITH COMMON CAROTID ARTERY TORTUOSITY, PROXIMAL TO THE LESION. IMAGES CONFIRM INFLATION OF BOTH THE GORE BALLOON WIRE (GBW) AND THE GORE BALLOON SHEATH (GBS). THE GBW APPEARED TO BE REPOSITIONED TO EXCLUDE THE EXTERNAL CAROTID ARTERY AND ITS BRANCH VESSELS. THE GBS WAS OBSERVED TO BE GROSSLY OVER-INFLATED, EXHIBITING AN ASYMMETRIC INFLATION AND LONGITUDINAL ELONGATION. ADEQUATE FLOW REVERSAL COULD NOT BE CONFIRMED FROM THE AVAILABLE ANGIOGRAPHIC IMAGES. THE CAUSE OF THE REPORTED NEUROLOGICAL DEFICIT COULD NOT BE IDENTIFIED FROM THE IMAGES PROVIDED. IMAGES OF INTRACRANIAL ARTERIAL VASCULATURE FOLLOWING THE STENTING WERE PROVIDED; HOWEVER, SIMILAR PRE-INTERVENTIONAL DIAGNOSTIC ANGIOGRAMS WERE NOT PROVIDED, SO IT IS NOT POSSIBLE TO DETECT PROCEDURE RELATED VESSEL BLOCKAGE OR ALTERED HEMODYNAMICS.

    Description of Event or Problem · 1

    IT WAS REPORTED A SYMPTOMATIC PT UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY. A GORE FLOW REVERSAL SYSTEM WAS USED FOR EMBOLIC PROTECTION. IMMEDIATELY UPON INFLATION OF THE GORE BALLOON SHEATH BALLOON, THE PT WAS UNABLE TO SPEAK. FLOW REVERSAL WAS CONFIRMED AND THE PHYSICIAN CONTINUED THE PROCEDURE. THE PT'S NEUROLOGICAL DEFICIT DID NOT RESOLVE. THERE WAS NO TREATMENT OR INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE FLOW REVERSAL SYSTEM NTE / TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPUTRE NTE W.L. GORE & ASSOCIATES 9594909

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other