BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1102466 · Received August 8, 2008

    Report

    Report Number
    9616695-2008-00119
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDING RELEVANT TO THIS REPORT. BASED ON THE INSTRUCTIONS FOR USE, THE PT EFFECTS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CAROTID STENTS. NO ACTION IS REQUIRED. NO DEVICE MALFUNCTION WAS REPORTED. (FRESH FROZEN PLASMA AND PLATELET TRANSFUSION).

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: CEREBRAL HEMORRHAGE/STROKE. TIME OF SYMPTOMS/AE: POST PROCEDURE. IT WAS REPORTED THAT SIX DAYS POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT EXPERIENCED DIFFICULTY SPEAKING, RIGHT SIDED HAND WEAKNESS, AND A RIGHT FACIAL DROOP, WAS BROUGHT TO THE HOSPITAL, AND A CT SCAN OF THE BRAIN REVEALED A LEFT-SIDED CEREBRAL HEMORRHAGE. THE PT WAS RE-HOSPITALIZED AND FRESH FROZEN PLASMA AND PLATELET TRANSFUSIONS WERE GIVEN. DILAUDID WAS ADMINISTERED FOR COMPLAINTS OF A HEADACHE. 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 33029-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S EMBOSHIELD EPD| HEPARIN