BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 1551412 · Received December 1, 2009

    Report

    Report Number
    2017233-2009-90044
    Event Type
    Death
    Date Received
    December 1, 2009
    Date of Event
    October 7, 2009
    Report Date
    December 1, 2009
    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

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. CASE FILMS WERE REVIEWED. RESULTS - THE DEVICE WAS NOT RETURNED AND THEREFORE, AN ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED. HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE CASE FILMS WERE RETURNED FOR EVALUATION. THE FIRST SERIES OF INTRACRANIAL IMAGES PROVIDED APPEAR IN THE SERIES AFTER THE PRE-PROCEDURAL CAROTID IMAGES WERE TAKEN. THE SECOND SERIES OF INTRACRANIAL IMAGES AVAILABLE APPEAR IN THE SERIES FOLLOWING STENT PLACEMENT. WHEN THE LATERAL PERSPECTIVES FROM THESE TWO RUNS ARE COMPARED THERE IS EVIDENCE OF DIFFERENCES IN THE FILLING OF THE MIDDLE CEREBRAL ARTERY (MCA) TERRITORY. THE IMAGES PROVIDED THAT INCLUDE THE GORE FLOW REVERSAL SYSTEM IN THE ANATOMY SHOW SUB-OPTIMAL OCCLUSION OF THE BRANCHES OF THE EXTERNAL CAROTID ARTERY (ECA). DIFFERENT IMAGES SHOW DIFFERENT LEVELS OF ECA OCCLUSION. THE SUB-OPTIMAL OCCLUSION OF THE ECA FIRST SLOWED FLOW REVERSAL, BUT DID NOT SEEM TO RESULT IN ANTEGRADE BLOOD FLOW IN THE INTERNAL CAROTID ARTERY. WITHOUT KNOWING MORE ABOUT THE POSITION OF THE STOP COCK, IT IS DIFFICULT TO DEFINITIVELY STATE THE LEVEL OF PROTECTION PROVIDED DURING STENT PLACEMENT. IN SUMMARY, THE IMAGES PROVIDED SHOW CHANGES IN THE BLOOD FLOW OF THE RIGHT MCA BETWEEN INTRACRANIAL RUNS TAKEN EARLY IN THE PROCEDURE AND THOSE TAKEN AFTER THE STENT WAS IN PLACE. THE FILLING DIFFERENCES IN THE MCA TERRITORY ARE CONSISTENT WITH THE CLINICAL STATUS OF THE PATIENT AS REPORTED IN THE EVENT DESCRIPTION.

    Description of Event or Problem · 1

    A GORE FLOW REVERSAL SYSTEM (GFRS) WAS USED FOR EMBOLIC PROTECTION DURING A CAROTID ARTERY STENTING AND ANGIOPLASTY PROCEDURE. DIAGNOSTIC IMAGING REVEALED A LARGE THROMBUS IN THE RIGHT COMMON CAROTID ARTERY/INTERNAL CAROTID ARTERY. THE PHYSICIAN CHOSE TO STENT THE THROMBUS. DURING DIAGNOSTIC IMAGING (FIRST INJECTION OF CONTRAST MEDIUM) THE PATIENT EXPERIENCED LEFT HEMIPARESIS. THE PHYSICIAN CHOSE TO CONTINUE THE PROCEDURE. THE GFRS WAS PLACED AND FLOW REVERSAL WAS ESTABLISHED. A STENT WAS PLACED SUCCESSFULLY, COVERING THE THROMBUS. POST-STENTING, THE PATIENT WAS STILL EXPERIENCING HEMIPARESIS AND IMAGES SHOWED AN OCCLUSION OF THE MIDDLE CEREBRAL ARTERY (MCA). FLOW REVERSAL WAS DISCONTINUED AND THROMBOLYSIS WAS PERFORMED. ONE BRANCH OF THE MCA WAS OPENED WITH UROKINASE; HOWEVER, TWO BRANCHES OF THE MCA REMAINED OCCLUDED. THE PATIENT EXPERIENCED INTRACEREBRAL HEMORRHAGE, WAS ADMITTED TO THE EMERGENCY DEPARTMENT IN CRITICAL CONDITION, AND LATER EXPIRED.

    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 06613610

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death