BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 20695510 · Received November 15, 2024

    Report

    Report Number
    2124215-2024-70921
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729579687
    PMA / PMN Number
    K133110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS 1: (B)(6). G4: G4: PMA/510(K) # FIELD ON 3500A FORM: P090003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL SUPERFICIAL FEMORAL ARTERY. A 6.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT SEPARATED FROM THE BALLOON, REQUIRING THE USE OF A SNARE TO SUCCESSFULLY RETRIEVE THE STENT AND REMOVE IT FROM THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324211 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047630130 0028863286 08714729579687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention