BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 23720233 · Received December 4, 2025

    Report

    Report Number
    2124215-2025-86016
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 7, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392439
    PMA / PMN Number
    K133110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 DEVICE WAS RETURNED FOR EVALUATION. A VISUAL AND TACTILE EXAMINATION IDENTIFIED THAT THE BALLOON WAS TIGHTLY FOLDED AND HAD NOT BEEN SUBJECT TO POSITIVE PRESSURE. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED THAT THE DISTAL END OF THE STENT WAS DAMAGED, AND WHERE THE STENT HAD BEEN PUSHED PROXIMALLY OVER THE PROXIMAL BALLOON CONE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE SHAFT AND TIP OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K133110, P090003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS SELECTED FOR USE IN A LEG ANGIOGRAM. DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF BALLOON. ANOTHER 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS USED, HOWEVER SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS SELECTED FOR USE IN A LEG ANGIOGRAM. DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF BALLOON. ANOTHER 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS USED, HOWEVER SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407177 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047720130 0036572974 08714729392439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown