BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 955072 · Received November 28, 2007

    Report

    Report Number
    6000089-2007-01608
    Event Type
    Injury
    Date Received
    November 28, 2007
    Date of Event
    October 23, 2007
    Report Date
    October 30, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED, THEREFORE A RETURNED PRODUCT ANALYSIS COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    SAME EVENT AS MFR# 2954755-2007-00045. IT WAS REPORTED THAT 2 HOURS POST PROCEDURE, THE PATIENT PRESENTED WITH RIGHT HEMIPARESIS. THE 10MM, 80% STENOTIC LESION WAS LOCATED AT BIFURCATION OF THE CAROTID ARTERY. THE VESSEL DIAMETER WAS 6MM. THE WALLSTENT AND FILTERWIRE EZ WERE SUCCESSFULLY USED AND THE ARTERY REMAINED PERMEABLE FOLLOWING THE PROCEDURE. THE PATIENT HAD BEEN STARTED ON ASPIRIN AND CLOPIDOGREL PRIOR TO THE PROCEDURE AND RECEIVED HEPARIN DURING THE PROCEDURE. TWO HOURS POST PROCEDURE, THE PATIENT PRESENTED WITH RIGHT HEMIPARESIS. THE PATIENT WAS TREATED WITH 325MG/DAY ASA AND 1 TAB/DAY CLOPIDOGREL AND CURRENTLY HAS SEVERE PARESIA AT THE RIGHT INFERIOR LIMB WITHOUT BRACHIAL OR FACIAL IMPACT. IN THE OPINION OF THE PHYSICIAN, THE HEMIPARESIS WAS NOT RELATED TO THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC 8.0 X 29MM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other