BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROTHESIS

    MDR report key: 1882930 · Received October 26, 2010

    Report

    Report Number
    2134265-2010-04778
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2010-04777. IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, NO FLOW OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT COMMON CAROTID/INTERNAL CAROTID ARTERY. THE LESION WAS PREDILATED. DURING THE DEPLOYMENT OF THE FILTERWIRE AND PLACEMENT OF THE CAROTID WALLSTENT, SLOW FLOW WAS CONFIRMED. POST DILATION WAS PERFORMED WITH AN UNKNOWN BALLOON. NO FLOW WAS CONFIRMED. IT WAS FURTHER INDICATED THAT CLOGGING OF THE FILTERWIRE OCCURRED. THE FILTERWIRE WAS REMOVED FROM THE PATIENT'S BODY AFTER THE CLOT WAS ASPIRATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT'S OUTCOME CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H749391508210 13364278

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention