BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2193183 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05551
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    May 3, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECTS OF HYPOTENSION AND TRANSIENT ISCHEMIC ATTACK ARE KNOWN, OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. THE EMBOSHIELD NAV 6 IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF NEUROLOGICAL EVENT AND WEAKNESS ARE KNOWN POTENTIAL ADVERSE EVENTS AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR REPORTED PATIENT ADVERSE EFFECTS AND RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PATIENT HAD AN EPISODE OF MILD HYPOTENSION AFTER STENT IMPLANTATION, WITH THE POST-DILATATION, WHICH WAS TREATED WITH NEOSYNEPHRINE. AFTER POST-DILATATION, THE PATIENT WAS NOTED TO HAVE SLOW FLOW IN THE INTERNAL CAROTID ARTERY. AN EXPORT CATHETER WAS USED TO ASPIRATE THE ARTERY, AND THE EMBOSHIELD NAV 6 FILTER WAS REMOVED. A MODERATE AMOUNT OF PARTICULATE MATTER WAS NOTED IN THE FILTER AS WELL AS A SMALL AMOUNT IN THE BLOOD REMOVED FROM THE EXPORT CATHETER. THE FOLLOWING DAY THE HYPOTENSION RESOLVED AND NEOSYNEPHRINE WAS STOPPED. AN ADJUDICATION OF THIS EVENT WAS COMPLETED, AND THE FINAL DIAGNOSIS WAS LISTED AS TRANSIENT ISCHEMIC ATTACK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE RIGHT-HANDED WEAKNESS POST XACT STENTING OF THE LEFT INTERNAL CAROTID ARTERY ON (B)(6) 2011. NO TREATMENT WAS GIVEN AND THERE WAS SOME RESIDUAL RIGHT-HANDED WEAKNESS UPON DISCHARGE (B)(6) 2011. ON (B)(6) 2011, 13 DAYS LATER, THE PATIENT EXPERIENCED RIGHT UPPER AND LOWER EXTREMITY PARESTHESIAS. IN ADDITION, THE PATIENT WAS NOTED TO BE IN ATRIAL FIBRILLATION, AND WAS TREATED WITH COUMADIN. HEAD CT SHOWED NO ACUTE DISEASE. RIGHT LEG SYMPTOMS RESOLVED BY DISCHARGE, BUT THE RIGHT HAND WEAKNESS PERSISTS. TIA WAS SUSPECTED IN BOTH INSTANCES, AND SYMPTOMS LASTED LONGER THAN 24 HOURS, BUT IT WAS UNCLEAR IF RELATED TO THE DEVICE/PROCEDURE OR THE PRE-EXISTING ATRIAL FIBRILLATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0082061

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| S EMBOSHIELD NAV6