BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 23861096 · Received December 21, 2025

    Report

    Report Number
    2124215-2025-92212
    Event Type
    Malfunction
    Date Received
    December 21, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392293
    PMA / PMN Number
    K133110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K133110, P090003. DEVICE EVALUATED BY MFR: THE EXPRESS LD WAS RETURNED FOR ANALYSIS. THE FIRST TWO ROWS OF THE PROXIMAL STENT STRUTS WERE FOUND TO BE LIFTED/DAMAGED. THE RECOMMENDED INTRODUCER SHEATH SIZE FOR THIS EXPRESS LD DEVICE AS PER IFU IS A 7FR SHEATH. THE INVESTIGATOR WAS UNABLE TO INSERT THE DEVICE INTO A BOSTON SCIENTIFIC INTRODUCER SHEATH AS THE STENT WAS DAMAGED, AND MORE INTERACTION COULD DAMAGE THE DEVICE FURTHER. A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON WAS TIGHTLY FOLDED AND HAD NOT BEEN SUBJECTED TO POSITIVE PRESSURE. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2025. IT WAS REPORTED THAT STENT WAS DIFFICULT TO INSERT. AN 8.0X60X75CM EXPRESS LD STENT WAS SELECTED FOR USE IN AN ILIAC STENTING PROCEDURE. DURING THE PROCEDURE, STENT WAS PREPARED ACCORDING TO STANDARD PROCEDURE BUT COULD NOT BE INTRODUCED INTO THE NON-BOSTON SCIENTIFIC SHEATH. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIRST TWO ROWS OF THE PROXIMAL STENT STRUTS WERE FOUND TO BE LIFTED/DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057632 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046860750 0031345519 08714729392293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown