BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 20750101 · Received November 21, 2024

    Report

    Report Number
    2124215-2024-71873
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE STENT CAME OFF FROM THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED BILATERAL COMMON ILIAC. TWO 10.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT BALLOON EXPANDABLE CATHETERS WERE SELECTED AND ADVANCED FOR BILATERAL COMMON ILIAC 'KISSING STENTS' PROCEDURE. HOWEVER, THE STENTS WERE DIFFICULT TO CROSS THE LESION, AND BOTH STENTS CAME OFF FROM THE BALLOON. A SMALLER DIAMETER MUSTANG BALLOON WAS USED TO CROSS THROUGH THE STENTS AND THEN FULLY DEPLOY THE TWO STENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631830 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047140130 0032795072 08714729392385

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention