BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1823406 · Received August 25, 2010

    Report

    Report Number
    3004742046-2010-00376
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY, THE REPORTED PT EFFECTS OF NEUROLOGICAL DEFICIT/DYSFUNCTION, HEADACHE AND SEIZURE ARE KNOWN ADVERSE EVENTS LISTED IN THE XACT INSTRUCTIONS FOR USE. IN THIS CASE, THE NEUROLOGICAL DEFICIT/DYSFUNCTION WAS TREATED WITH MEDICATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): HYPERPERFUSION SYNDROME. TIME OF AE: POST PROCEDURE. IT WAS REPORTED VIA TRIAL THAT 2 DAYS POST SUCCESSFUL STENT IMPLANT IN THE RIGHT INTERNAL CAROTID ARTERY THE PT WAS HOSPITALIZED WITH HYPERPERFUSION SYNDROME, ELEVATED BLOOD PRESSURE OF 205/102, BITEMPORAL HEADACHES, LEFT SIDED WEAKNESS, SEIZURE ACTIVITY, TONGUE DEVIATION TO THE LEFT, AND INABILITY TO TURN EYES OR HEAD TO THE RIGHT. CT SCANS X2, AND MRI REVEALED NO ACUTE HEMORRHAGE. THE EVENT WAS TREATED WITH ANTIHYPERTENSIVE MEDICATIONS INCLUDING LISINOPRIL WHICH WAS RESUMED. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2010. REPORTEDLY, CONCOMITANT MEDICATIONS CHANTIX, XANAX, FLEXERIL OR NORCO COULD HAVE CONTRIBUTED TO THE SEIZURE ACTIVITY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 9103051

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R OTHER BIVALIRUDIN| (22438-19, LOT # 0051751)| EMBOLIC PROTECTION: EMBOSHIELD NAV 6,