BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 22664790 · Received July 30, 2025

    Report

    Report Number
    2124215-2025-51242
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729579670
    PMA / PMN Number
    K133110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AND THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X30X75CM EXPRESS LD BALLOON STENT WAS USED FOR PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND MOVED TO THE AORTA. ATTEMPTS WERE MADE TO SNARE AND RETRIEVE THE STENT, BUT THESE EFFORTS WERE UNSUCCESSFUL, AS THE STENT COULD NOT BE CAPTURED. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AND THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X30X75CM EXPRESS LD BALLOON STENT WAS USED FOR PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND MOVED TO THE AORTA. ATTEMPTS WERE MADE TO SNARE AND RETRIEVE THE STENT, BUT THESE EFFORTS WERE UNSUCCESSFUL, AS THE STENT COULD NOT BE CAPTURED. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ILIAC ARTERY WAS CALCIFIED AND THERE WAS RESISTANCE IN THE VESSEL UPON ADVANCING THE STENT SYSTEM. THERE WERE NO FURTHER ATTEMPTS PLANNED TO REMOVE THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49935 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046830750 0033345235 08714729579670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention