BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 25056213 · Received May 1, 2026

    Report

    Report Number
    2124215-2026-23746
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392477
    PMA / PMN Number
    K133110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. G4: PREMARKET / 510(K): K133110, P090003.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K133110, P090003. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE PRODUCT STATUS AND ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN ARTERY. AN UNKNOWN 6F X 70 CM SHEATH WAS PLACED, AND THE LESION WAS CROSSED WITH AN UNKNOWN 0.035-INCH GUIDEWIRE. DUE TO THE SEVERITY OF THE STENOSIS, AN UNKNOWN 6.0 X 40 MM BALLOON CATHETER WAS INFLATED TO PRE-DILATE THE LESION AND FACILITATE STENT DELIVERY. AN 8.0 X 40 MM X 135 CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED TO THE LESION; HOWEVER, DESPITE MULTIPLE ATTEMPTS, IT COULD NOT BE ADVANCED ACROSS THE STENOSIS. DURING WITHDRAWAL, THE STENT DISLODGED FROM THE BALLOON WITHIN THE SHEATH. THE DISLODGED STENT REMAINED ENTIRELY WITHIN THE SHEATH, WHICH WAS SUBSEQUENTLY REMOVED, AND THE STENT WAS RETRIEVED INTACT. A NEW SHEATH WAS INSERTED, AND AN AMPLATZ GUIDEWIRE WAS PLACED. A NEW EXPRESS LD STENT OF THE SAME SIZE WAS SUCCESSFULLY ADVANCED AND DEPLOYED ACROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LESION WAS LOCATED IN THE ILIAC ARTERY WITH 50% RESIDUAL STENOSIS POST-BALLOONING. THE PATIENT ANATOMY WAS NOTED TO BE CHALLENGING, AND PATIENT FACTORS WERE CONSIDERED CONTRIBUTORY TO THE REPORTED EVENT. PROCEDURAL FACTORS WERE NOT CONSIDERED CONTRIBUTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN ARTERY. A 6F X 70 CM SHEATH WAS PLACED, AND THE LESION WAS CROSSED WITH A 0.035-INCH GUIDEWIRE. DUE TO THE SEVERITY OF THE STENOSIS, A 6.0 X 40 MM BALLOON CATHETER WAS INFLATED TO PRE-DILATE THE LESION AND FACILITATE STENT DELIVERY. AN 8.0 X 40 MM X 135 CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED TO THE LESION; HOWEVER, DESPITE MULTIPLE ATTEMPTS, IT COULD NOT BE ADVANCED ACROSS THE STENOSIS. DURING WITHDRAWAL, THE STENT DISLODGED FROM THE BALLOON WITHIN THE SHEATH. THE DISLODGED STENT REMAINED ENTIRELY WITHIN THE SHEATH, WHICH WAS SUBSEQUENTLY REMOVED, AND THE STENT WAS RETRIEVED INTACT. A NEW SHEATH WAS INSERTED, AND AN AMPLATZ GUIDEWIRE WAS PLACED. A NEW EXPRESS LD STENT OF THE SAME SIZE WAS SUCCESSFULLY ADVANCED AND DEPLOYED ACROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145427 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047840130 0038608076 08714729392477

    Patients

    Seq Age Sex Outcome Treatment
    1