BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 3800212 · Received May 8, 2014

    Report

    Report Number
    2134265-2014-02455
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    January 22, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION REVEALED THAT THE STENT HAD ALSO MOVED 9MM PROXIMALLY AND THE PROXIMAL MARKERBAND WAS NOT VISIBLE AS A RESULT. STENT CRIMP MARKS WERE CLEARLY VISIBLE ON THE BALLOON INDICATING THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE SHAFT OF THE RETURNED DEVICE WAS KINKED 8CM PROXIMAL TO THE DISTAL TIP. AS THE STENT HAD MOVED ON THE BALLOON IT WAS NOT POSSIBLE TO ADVANCE IT THROUGH A 6FR SHEATH. 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 MDR ID: 2134265-2014-00539. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CATHETER DIFFICULTY IN ADVANCING THROUGH THE SHEATH OCCURRED. A 8.0MM X 20MM X 75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED; HOWEVER, IT WOULD NOT MOVE THROUGH THE 6FR NON-BSC SHEATH. THE DEVICE WAS REMOVED AND WAS REPLACED WITH A 8.0MM X 20MM X 135 CM EXPRESS LD ILIAC / BILIARY STENT. THE SECOND DEVICE WAS ADVANCED HOWEVER IT WAS NOTED THAT THE STENT MOVED ON THE BALLOON OF THE STENT DELIVERY SYSTEM WHILE STILL INSIDE THE SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH GOOD RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT MOVED ON BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279375 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046820750 0016067424

    Patients

    Seq Age Sex Outcome Treatment
    1