BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1902002 · Received November 12, 2010

    Report

    Report Number
    3004742046-2010-00537
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 22, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE, STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. BASED ON AVAILABLE INFO, A DEFINITIVE CAUSE FOR THE REPORTED PT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT POST A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE WITH AN XACT STENT, THE PT EXPERIENCED RIGHT SIDED WEAKNESS AND RIGHT SIDED FACIAL DROOP, DIAGNOSED AS A STROKE. THE PT REMAINED STABLE UNTIL THE NEXT MORNING WHEN APHASIA AND LEFT SIDED CHANGES DEVELOPED. ON (B)(6) 2010, THE PT'S STATUS WAS IMPROVED WITH ONLY SOME RESIDUAL SYMPTOMS. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0080661

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| S OTHER: HEPARIN