BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1051059 · Received May 22, 2008

    Report

    Report Number
    9616695-2008-00081
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 29, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. EMBOLISM AND STROKE ARE KNOWN POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF CAROTID STENTS AS STATED IN XACT INSTRUCTIONS FOR USE. THERE WAS NO DEVICE MALFUNCTION REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: STROKE. TIME OF AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT HAD A LEFT CEREBRAL STROKE. THE PT DEVELOPED RIGHT SIDED WEAKNESS ON THE EVENING OF THE PROCEDURE. A HEAD CT WAS DONE AND SHOWED ONLY CHRONIC SMALL VESSEL CHANGES, HOWEVER, A NEUROLOGY CONSULT ONE DAY POST PROCEDURE FOUND A SMALL ISCHEMIC STROKE WITH MOTOR INVOLVEMENT ONLY, THOUGHT TO BE SECONDARY FROM MICRO PARTICULATE DISTAL EMBOLI. THE PT WAS TREATED WITH ANTIPLATELET AGENTS. WHEN THE PT WAS DEEMED STABLE, PHYSICAL AND OCCUPATIONAL THERAPY WERE STARTED. THREE DAYS POST PROCEDURE, THE PT WAS DISCHARGED TO A REHABILITATION FACILITY. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 444559

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| S EMBOSHIELD EMBOLIC PROTECTION DEVICE| ANGIO SEAL