BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2539155 · Received April 10, 2012

    Report

    Report Number
    2017233-2012-00233
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 21, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS DISCARDED, SO NO ENGINEER INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT UNDERWENT CAROTID ARTERY STENTING. THE PT PRESENTED WITH ACUTE ISCHEMIC STROKE WITH COMPLETE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY (RICA). THE PHYSICIAN'S GOAL WAS TO REVASCULARIZE THE RICA AND THEN REMOVE THE CLOT IN THE RIGHT MIDDLE CEREBRAL ARTERY (RMCA). THE PHYSICIAN STARTED WITH EMBOSHIELD NAV6 FILTER FOR EMBOLIC PROTECTION HOWEVER DUE TO AN INADEQUATE LANDING ZONE, THE FILTER WAS REMOVED AND A GORE FLOW REVERSAL SYSTEM (GFRS) WAS INTRODUCED. SET-UP OF THE GFRS WAS COMPLETED WITHOUT ISSUE. DURING DEPLOYMENT OF THE STENT (7-9 X 30 XACT), THE GORE BALLOON WIRE (GBW) MIGRATED INTO THE COMMON CAROTID ARTERY. THE EXTERNAL CAROTID ARTERY WAS NO LONGER OCCLUDED. THE STENT WAS DEPLOYED, AND THE GBW WAS DEFLATED AND REMOVED. ASPIRATION WAS PERFORMED DURING STENT PLACEMENT, AND THE GORE BALLOON SHEATH BALLOON WAS DEFLATED. SINCE THE PT PRESENTED WITH A NEUROLOGICAL DEFICIT AND A KNOWN CLOT IN THE RMCA, IT CANNOT BE DETERMINED IF THERE WAS ADDITIONAL EMBOLIZATION OR FURTHER NEUROLOGICAL DEFICIT AS A RESULT OF THE GBW MIGRATION. THE CLOT IN THE RMCA WAS TREATED WITH A THROMBOLYTIC AGENT, RETEPLASE, AND THE PROCEDURE ENDED. THE PRODUCT ENDED. THE PRODUCT SPECIALIST VISUALLY INSPECTED THE GBW AND HE SAW NOTHING TO INDICATE THE GBW WAS DISCREPANT OR DAMAGED.

    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 9594879

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR