BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2000014 · Received February 17, 2011

    Report

    Report Number
    2017233-2011-00072
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 16, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. AN ENGINEERING EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. EXAMINATION OF THE COMMON CAROTID ARTERY HEMOSTASIS VALVE COMPONENTS REVEALED A SMALL TEAR IN THE SILICONE TUBE. MEASUREMENTS OF THE TUBE INDICATED IT MET SPECIFICATIONS. NO IRREGULARITIES (VISIBLE OR MEASURED) OF THE REMAINING VALVE COMPONENTS WERE NOTED. NO ISSUES WERE REPORTED UNTIL STENT DEPLOYMENT WAS ATTEMPTED. THIS OBSERVATION SUGGESTS THAT THE VALVE WAS NORMAL WHEN THE DEVICE WAS OPENED, PREPARED AND DELIVERED IN THE PATIENT. IN ADDITION, A SECOND STENT DELIVERY AND POST DILATION WERE REPORTED WITH NO INTERACTION DIFFICULTIES NOTED. BASED ON THE ENGINEERING ANALYSIS, THE CAUSE FOR THE VALVE MALFUNCTION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING STENT DEPLOYMENT, THE PHYSICIAN EXPERIENCED HIGH FRICTION AND WAS UNABLE TO DEPLOY THE STENT. THE PHYSICIAN RETRACTED THE GORE BALLOON SHEATH (GBS) AND STENT DELIVERY SYSTEM TOGETHER TO DEPLOY THE STENT. AS THE GBS WAS RETRACTED, THE GORE BALLOON WIRE (GBW) BALLOON BECAME DISLODGED FROM THE EXTERNAL CAROTID ARTERY. THE GBW BALLOON WAS NOT REPOSITIONED; A SECOND STENT WAS DEPLOYED, POST DILATATION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    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 8673639

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR ZILVER STENTS (2):