BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1053607 · Received May 23, 2008

    Report

    Report Number
    2134265-2008-01499
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION AND THE STENT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ANGIOPLASTY PROCEDURE, DEPLOYMENT DIFFICULTIES OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. FIRST, A FILTERWIRE EZ WAS ADVANCED. AS THE CAROTID WALLSTENT WAS BEING DEPLOYED, FRICTION BY THE SHAFT WAS NOTED AT THE PROXIMAL END OF THE STENT. THEREFORE, THE STENT WAS DISPLACED AND DEPLOYED "BENEATH" THE LESION. ANOTHER CAROTID WALLSTENT WAS THEN DEPLOYED TO FULLY COVER THE LESION. POST DILATION WAS PERFORMED WITH ANOTHER MANUFACTURER'S BALLOON. PT STATUS WAS REPORTED AS 'STABLE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC 8.0 X 21MM 9358667

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention