BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2195504 · Received August 1, 2011

    Report

    Report Number
    2017233-2011-00388
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    August 1, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE LOT # IS UNKNOWN AND UNAVAILABLE. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE DEVICE WAS DISCARDED, SO NO ENGINEERING ANALYSIS OF THE DEVICE IS POSSIBLE. RESULTS: A REVIEW OF FLUOROSCOPY IMAGES IN INCLUDED BELOW. IMAGE REVIEW SUMMARY: IMAGES CONFIRM INFLATION OF GORE BALLOON SHEATH (GBS) AND GORE BALLOON WIRE (GBW) BALLOONS. THE FLOW REVERSAL CONFIRMATION RUN DOES NOT SHOW CLEAR FLOW REVERSAL IN THE INTERNAL CAROTID ARTERY (ICA). IMAGES CONFIRM STENT DEPLOYMENT AND AT LEAST THREE POST DILATATION BALLOON INFLATIONS. IMAGES SHOW THAT THE GBS BALLOON SHAPE IS VERY ASYMMETRICAL AND EXTENDS SLIGHTLY PAST THE DISTAL END OF THE GBS CATHETER SHAFT. AN ASYMMETRICAL GBS BALLOON THAT EXTENDS BEYOND THE DISTAL END OF THE CATHETER IS OFTEN DUE TO OVERINFLATION OF THE GBS BALLOON. IT IS NOT CLEAR IF THIS AFFECTED ESTABLISHMENT OF EMBOLIC PROTECTION OR THE OUTCOME OF THE PROCEDURE. IMAGES SHOW A LARGE STATIONARY FILLING DEFECT THAT IS PRESENT THROUGHOUT SEVERAL ANGIOGRAPHIC RUNS AND THEN IS NOT PRESENT DURING LATER ANGIOGRAPHIC RUNS. AVAILABLE INFORMATION IS NOT DEFINITIVE, BUT THE STATIONARY FILLING DEFECT COULD BE AN EMBOLIC MASS OR AIR EMBOLI. IT IS NOT CLEAR IF THIS FILLING DEFECT TRAVELED TO THE BRAIN. IMAGES SHOW A LARGE MOBILE THROMBUS OR AIR EMBOLI ON TWO OCCASIONS THROUGHOUT THE PROCEDURE. AT LEAST ONE OF THE MOBILE THROMBUS/AIR EMBOLI APPEARS TO EXIT THE GBS CATHETER DURING THE CONTRAST INJECTION. AIR ENTRAINMENT INTO THE GBS HUB FOLLOWED BY A CONTRAST INJECTION OR NEGLECTING TO ASPIRATE PRIOR TO A CONTRAST INJECTION ARE POTENTIAL SOURCES OF MOBILE THROMBUS/AIR EMBOLI. IT IS NOT CLEAR IF EITHER LARGE MOBILE THROMBUS/AIR EMBOLI TRAVELED TO THE BRAIN. IMAGES SHOW WHAT APPEARS TO BE OCCLUSION OF A BRANCH VESSEL OF THE MIDDLE CEREBRAL ARTERY FOLLOWING THE CAROTID INTERVENTION. HOWEVER, IT CANNOT BE CONFIRMED THAT THIS APPARENT OCCLUSION IS THE RESULT OF THE PROCEDURE SINCE THERE ARE NO BASELINE/PRE-PROCEDURAL IMAGES.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A CAROTID ARTERY STENTING PROCEDURE. A GORE FLOW REVERSAL SYSTEM WAS USED FOR EMBOLIC PROTECTION. DURING THE IMPLANTATION OF A WALLSTENT DEVICE, A THROMBUS WAS NOTED. THE PHYSICIAN TRIED TO DO ACTIVE ASPIRATION BUT HE COULD NOT REMOVE THE THROMBUS AND THE PATIENT SUFFERED A STROKE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability HEPARIN DURING PROCEDURE