BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1830880 · Received September 8, 2010

    Report

    Report Number
    3004742046-2010-00404
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    July 5, 2010
    Report Date
    August 13, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF NEUROLOGICAL DEFICIT/DYSFUNCTION, AND VISUAL DISTURBANCES ARE KNOWN ADVERSE EVENTS LISTED IN THE XACT INSTRUCTIONS FOR USE. 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 MFR, DESIGN OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): VISUAL FIELD DEFICIT. TIME OF AE: POST PROCEDURE. IT WAS REPORTED VIA TRIAL THAT 3 DAYS POST SUCCESSFUL STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY, THE PT EXPERIENCED INTERMITTENT BLURRED VISION IN THE LEFT LOWER VISUAL QUADRANT. CAROTID ULTRASOUND, DONE ON (B)(6) 2010, SHOWED A PT STENT. AT THAT TIME, THE PHYSICIAN FELT THE BLURRED VISION WAS UNRELATED TO THE STENT AND NO TREATMENT WAS GIVEN. HOWEVER, THE INTERMITTENT BLURRED VISION PERSISTED 30 DAYS POST PROCEDURE. ALTHOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0050461

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability EMBOSHIELD NAV 6 (22438-19, LOT # 0050561)| BIVALIRUDIN