BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 23414458 · Received October 29, 2025

    Report

    Report Number
    2124215-2025-76790
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392156
    PMA / PMN Number
    K133110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). G4: PREMARKET / 510(K) #: K133110, P090003.

    Additional Manufacturer Narrative · 0

    (B)(6). G4: PREMARKET / 510(K) #: K133110, P090003. DEVICE EVALUATED BY MFR: THE EXPRESS LD DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL AND TACTILE EXAMINATION IDENTIFIED THAT THE BALLOON WAS TIGHTLY FOLDED AND HAD NOT BEEN SUBJECT TO POSITIVE PRESSURE. NO ISSUES WAS NOTED WITH THE BALLOON MATERIAL. THE DEVICE WAS RECEIVED WITH THE STENT SEPARATED FROM THE BALLOON. THE STENT WAS NOTED TO BE DAMAGED. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE SHAFT AND TIP OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL MESENTERIC ARTERY. A 6.0X40X75CM EXPRESS LD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS PLACED OVER A GUIDEWIRE, BUT THE PHYSICIAN OBSERVED THAT THE STENT WAS TOO LONG FOR THE LESION. WHILE REMOVING THE STENT SYSTEM, UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE STENT WAS COMING OFF THE BALLOON. THE PHYSICIAN IMMEDIATELY STOPPED, THEN ADVANCED THE SYSTEM FORWARD TO RETRIEVE THE STENT AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THE STENT DID NOT COMPLETELY DISLODGE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL MESENTERIC ARTERY. A 6.0X40X75CM EXPRESS LD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS PLACED OVER A GUIDEWIRE, BUT THE PHYSICIAN OBSERVED THAT THE STENT WAS TOO LONG FOR THE LESION. WHILE REMOVING THE STENT SYSTEM, UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE STENT WAS COMING OFF THE BALLOON. THE PHYSICIAN IMMEDIATELY STOPPED, THEN ADVANCED THE SYSTEM FORWARD TO RETRIEVE THE STENT AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THE STENT DID NOT COMPLETELY DISLODGE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557535 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046640750 0035889056 08714729392156

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male