BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 24388565 · Received February 19, 2026

    Report

    Report Number
    2124215-2026-09286
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392217
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K133110, P090003 DEVICE EVALUATION BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND TACTILE INSPECTION REVEALED THAT THE BALLOON REMAINED TIGHTLY FOLDED WITH NO EVIDENCE OF PRIOR INFLATION OR EXPOSURE TO POSITIVE PRESSURE, AND NO ABNORMALITIES WERE OBSERVED IN THE BALLOON MATERIAL. EXAMINATION OF THE CRIMPED STENT SHOWED THAT IT HAD BEEN RECEIVED ALREADY DETACHED FROM THE BALLOON AND WAS NOTED TO BE DAMAGED. FURTHER VISUAL AND TACTILE EVALUATION IDENTIFIED NO ABNORMALITIES IN THE DEVICE SHAFT OR TIP. DEVICE HISTORY RECORDS (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT 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 REPORTED EVENT IS A KNOWN EVENT DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC CONCLUDES THE MOST PROBABLE ROOT CAUSE AS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. IT WAS REPORTED THAT THE STENT WAS FOUND TO BE LOOSE AND DISPLACED FROM THE BALLOON CATHETER DURING PREPARATION FOR THE PROCEDURE. THERE WAS NO REPORT OF DEVICE DAMAGE, DEFECT, OR MALFUNCTION DURING USE, AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE INSTRUCTIONS FOR USE FOUND DEVICE HANDLING AND PREPARATION PRECAUTIONS LISTED AS POTENTIAL CONTRIBUTING FACTORS, SUGGESTING THE REPORTED EVENT IS CONSISTENT WITH UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 40 X 75 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR USE. UPON PREPARATION, IT WAS OBSERVED THAT THE STENT WAS NOT MOUNTED ON THE BALLOON PRIOR TO USE, AND STENT DAMAGE WAS NOTED. THE AFFECTED DEVICE WAS NOT USED FOR TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 40 X 75 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR USE. UPON PREPARATION, IT WAS OBSERVED THAT THE STENT WAS NOT MOUNTED ON THE BALLOON PRIOR TO USE, AND STENT DAMAGE WAS NOTED. THE AFFECTED DEVICE WAS NOT USED FOR TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458224 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046740750 0035910066 08714729392217

    Patients

    Seq Age Sex Outcome Treatment
    1