BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1963055 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05911
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 20, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT MIGRATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE PATIENT PRESENT WITH A VESSEL DISSECTION LOCATED IN THE RIGHT COMMON CAROTID ARTERY. A 10.0-24 CAROTID WALLSTENT (CWS) WAS ADVANCED TO THE TARGET LOCATION AND SUCCESSFULLY DEPLOYED. HOWEVER, IMMEDIATELY AFTER DEPLOYMENT THE STENT MIGRATED TO THE DISTAL COMMON CAROTID ARTERY, AND WAS FULLY APPOSED TO THE VESSEL WALL. ANOTHER OF THE SAME CWS WAS IMMEDIATELY DEPLOYED AT THE TARGET LOCATION TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647120 13767699

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GUIDE WIRE, FILTER WIRE EZ| INTRODUCER SHEATH, 6FR COOK SHUTTLE