BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS (R) LD ILIAC / BILIARY

    MDR report key: 2212525 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03360
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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, STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS LEFT SUBCLAVIAN ARTERY. THIS 7.0X20X135CM EXPRESS BILIARY LD STENT WAS ADVANCED AND DEPLOYED IN THE LESION. THE STENT WAS FULLY EXPANDED; HOWEVER, IT WAS DEPLOYED SLIGHTLY DISTAL FROM THE TARGET AREA. A PORTION OF THE STENT WAS LOCATED IN AN AREA NOT INTENDED TO BE STENTED. AFTER A FEW MINUTES AT MOST FROM STENT DEPLOYMENT, THE STENT MIGRATED INTO THE LEFT ILIAC ARTERY. THE STENT CAME TO REST IN A STENOSED AREA IN THIS LOCATION AND WAS EXPANDED TO VESSEL DIAMETER SUCCESSFULLY. THE PROCEDURE WAS COMPLETED BY IMPLANTING A LARGER STENT IN THE TARGET LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (R) LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938047720130 0013471741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention