BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 1916320 · Received November 30, 2010

    Report

    Report Number
    2017233-2010-00533
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 29, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN IMAGING EVAL AND A REVIEW OF THE MFG PAPERWORK HAVE BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. AN IMAGING EVAL CONFIRMED A DISEASED EXTERNAL CAROTID ARTERY (ECA), BUT THE AVAILABLE IMAGE CANNOT CONFIRM ECA ACCESS DIFFICULTIES, THE ADVANCEMENT OF AN ALTERNATIVE OCCLUSION DEVICE, OR THE REPORTED NEUROLOGICAL AND PHYSIOLOGICAL SYMPTOMS. THE DEVICE WAS NOT RETURNED AND THEREFORE, AN ENGINEERING ANALYSIS WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A PT WAS PREPPED FOR A CAROTID ARTERY STENTING PROCEDURE. A GORE FLOW REVERSAL SYSTEM WAS CHOSEN FOR EMBOLIC PROTECTION. UPON GAINING GROIN ACCESS, THE PT'S EKG LEVELS ELEVATED. AN ANGIOGRAM OF THE CORONARY ARTERIES REVEALED A RIGHT CORONARY ARTERY STENOSIS. THE PHYSICIAN CHOSE TO CONTINUE WITH THE CAROTID PROCEDURE. THE GORE BALLOON SHEATH WAS POSITIONED; HOWEVER, THE GORE BALLOON WIRE (GBW) WAS UNABLE TO ADVANCED INTO THE DISEASED EXTERNAL CAROTID ARTERY (ECA). THE GBW WAS REMOVED, AND AS ANOTHER BALLOON DEVICE WAS BEING ADVANCED TO THE ECA, THE PT BECAME BRADYCARDIC, HYPOTENSIVE, AND WAS UNRESPONSIVE TO COMMANDS. ATROPINE WAS ADMINISTERED AND THE PT'S NEUROLOGICAL STATUS QUICKLY RETURNED TO BASELINE, AND THE BRADYCARDIA AND HYPOTENSION RESOLVED. A CEREBRAL ANGIOGRAM WAS PERFORMED AND COMPARED TO THE PRE-PROCEDURAL CEREBRAL ANGIOGRAM. THERE WERE NO NOTICEABLE DIFFERENCES BETWEEN THE ANGIOGRAMS. THE PHYSICIAN ABORTED THE CAROTID ARTERY STENTING PROCEDURE AND CONVERTED TO CORONARY ARTERY STENTING, WHICH WAS COMPLETED SUCCESSFULLY.

    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 8177348

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention