BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1172144 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02720
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, SHEATH BREAKAGE OCCURRED. THE 40MM LONG MODERATELY CALCIFIED AND 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE INTERNAL CAROTID ARTERY. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE CAROTID WALLSTENT MR DELIVERY DEVICE. DURING DEPLOYMENT OF THE CAROTID WALLSTENT MR, THE SHEATH BROKE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE SDS WITH THE UNSPECIFIED MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER MFR'S STENT. NO PT COMPLICATIONS WERE REPORTED, THE 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 10.0 X 37MM 0009440851

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR