BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1772373 · Received July 23, 2010

    Report

    Report Number
    3004742046-2010-00330
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 29, 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). THE STENT REMAINS IN THE PT. THE LOT# WAS PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): TRANSIENT ISCHEMIC ATTACK (TIA). IT WAS REPORTED VIA A TRIAL THAT ONE DAY POST A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT EXPERIENCED A TIA. SYMPTOMS INCLUDED SEVERE APHASIA AND SLURRING OF WORDS. ON (B)(6) 2010, THE EVENT RESOLVED AND THE PT WAS DISCHARGED TO HOME. 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 9091551

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| S HEPARIN| EMBOLIC PROTECTION: EMBOSHIELD NAV 6| (B)(4), LOT# 0050651),