BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 24689104 · Received March 25, 2026

    Report

    Report Number
    2124215-2026-16322
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729579700
    PMA / PMN Number
    K133110
    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. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K133110, P090003. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE EXPRESS LD DEVICE CONFIRMED THAT THE STENT - DISLODGED INSIDE THE PATIENT IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT ANATOMY AND/ OR CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN 8.0 X 30 MM X 135 CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM WAS ADVANCED; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE AORTIC ARCH. UPON CROSSING THE CALCIFIED LESION, THE STENT DISLODGED FROM THE DELIVERY BALLOON. THE STENT MIGRATED FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ELECTED TO KEEP THE DISLODGED STENT AND USED A BALLOON TO EXPAND IT AGAINST THE VESSEL WALL AT THE EXTERNAL ILIAC ARTERY WITHIN THE DISEASED SEGMENT. THE STENT WAS NOT REMOVED, AS THE PHYSICIAN DETERMINED IT WAS ACCEPTABLE TO DEPLOY IT AT THAT LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 80% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN 8.0 X 30 MM X 135 CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM WAS ADVANCED; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE AORTIC ARCH. UPON CROSSING THE CALCIFIED LESION, THE STENT DISLODGED FROM THE DELIVERY BALLOON. THE STENT MIGRATED FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ELECTED TO KEEP THE DISLODGED STENT AND USED A BALLOON TO EXPAND IT AGAINST THE VESSEL WALL AT THE EXTERNAL ILIAC ARTERY WITHIN THE DISEASED SEGMENT. THE STENT WAS NOT REMOVED, AS THE PHYSICIAN DETERMINED IT WAS ACCEPTABLE TO DEPLOY IT AT THAT LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533127 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047830130 0036739150 08714729579700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention