BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 3013321 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01671
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE SHAFT WAS SEVERELY STRETCHED AT APPROXIMATELY 600MM DISTAL TO THE STRAIN RELIEF FOR A DISTANCE OF 290MM. THE DISTAL PORTION OF THE DEVICE INCLUDING THE BALLOON WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-01759. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE ADVANCING THE 9.0X30MM EXPRESS LD SDS OVER AN AMPLATZ SUPER STIFF GUIDE WIRE, IT BECAME STUCK. THE DEVICES WERE WITHDRAWN FROM THE PATIENT AND THE SDS AND WIRE WERE CUT TO REMOVE THE SDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPRESS LD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-01759. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE ADVANCING THE 9.0X30MM EXPRESS LD SDS OVER AN AMPLATZ SUPER STIFF GUIDE WIRE, IT BECAME STUCK. THE DEVICES WERE WITHDRAWN FROM THE PATIENT AND THE SDS AND WIRE WERE CUT TO REMOVE THE SDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPRESS LD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116829 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046920750 15694345

    Patients

    Seq Age Sex Outcome Treatment
    1