BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 24947984 · Received April 21, 2026

    Report

    Report Number
    2124215-2026-21647
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392453
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, REQUIRING AN ADDITIONAL DEVICE. THE PATIENT WAS BEING TREATED FOR AN OCCLUDED ILIAC ARTERY AND WAS SCHEDULED FOR LEFT LEG ANGIOPLASTY. ACCESS WAS VIA PEDAL APPROACH TO A 90% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. WHILE ADVANCING A 7.0X60X135 CM EXPRESS LD STENT, IT SHIFTED APPROXIMATELY 0.25CM ON THE BALLOON. IT WAS DECIDED TO REMOVE THE STENT TO REPLACE IT; HOWEVER, DURING WITHDRAWAL, THE STENT CONTINUED TO MOVE FURTHER OFF THE BALLOON. WHEN THE STENT WAS IN THE MID-ANTERIOR TIBIAL ARTERY, THE STENT WAS 90% OFF THE BALLOON. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON SLIGHTLY TO BETTER GRIP THE STENT; HOWEVER, IT WAS UNSUCCESSFUL AND IT WAS NOTED THAT THE STENT COMPLETELY DISLODGED FROM THE BALLOON. THE BALLOON WAS WITHDRAWN AND THE STENT REMAINED IN THE ANTERIOR TIBIAL ARTERY. A 3X120 STERLING BALLOON WAS USED TO EXPAND AND APPOSE THE STENT TO THE 3MM VESSEL DIAMETER AND BLOOD FLOW WAS CONFIRMED. TEMPORARY EXTRAVASATION AND PROLONGED PROCEDURE WERE NOTED. THE PATIENT WAS RESCHEDULED FOR ADDITIONAL STENTING AND WAS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148269 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047760130 0038141891 08714729392453

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention