BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 21294720 · Received February 3, 2025

    Report

    Report Number
    2124215-2025-05234
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729579656
    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

    G4 - PREMARKET / 510(K) #: K133110, P090003. DEVICE EVAL BY MFR: THE DEVICE WAS NOT RETURNED. HOWEVER, A PHOTO WAS PROVIDED FROM THE HEALTHCARE FACILITY, SHOWING DAMAGE TO THE STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENTS DISLODGED AND REQUIRED SURGICAL INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERIOR MESENTERIC ARTERY (SMA). A 6.0X20X75CM EXPRESS LD BALLOON EXPANDABLE STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT TRACK THROUGH THE SMA, AND THE BALLOON RUPTURED WITHOUT BEING FULLY INFLATED. SUBSEQUENTLY, THE STENT FRACTURED AND DISLODGED FROM THE BALLOON AND GOT STUCK IN THE SMA THEN MIGRATED DOWN TO THE POPLITEAL ARTERY. THE SAME ISSUE OCCURRED WHEN ANOTHER EXPRESS LD BALLOON EXPANDABLE STENT WAS USED. THE PHYSICIAN ATTEMPTED TO SNARE THE DISLODGED STENTS BUT WAS UNSUCCESSFUL. AS A RESULT, AN EMERGENCY CUTDOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE STENTS, AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE BUT IS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE STENT WAS USED FOR MESENTERIC ANGIOGRAM. FURTHERMORE, IT WAS NOTED THAT THE STENT WAS DEPLOYED WITHOUT PHYSICIAN INITIATING THE DEPLOYMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENTS DISLODGED AND REQUIRED SURGICAL INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERIOR MESENTERIC ARTERY (SMA). A 6.0X20X75CM EXPRESS LD BALLOON EXPANDABLE STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT TRACK THROUGH THE SMA, AND THE BALLOON RUPTURED WITHOUT BEING FULLY INFLATED. SUBSEQUENTLY, THE STENT FRACTURED AND DISLODGED FROM THE BALLOON AND GOT STUCK IN THE SMA THEN MIGRATED DOWN TO THE POPLITEAL ARTERY. THE SAME ISSUE OCCURRED WHEN ANOTHER EXPRESS LD BALLOON EXPANDABLE STENT WAS USED. THE PHYSICIAN ATTEMPTED TO SNARE THE DISLODGED STENTS BUT WAS UNSUCCESSFUL. AS A RESULT, AN EMERGENCY CUTDOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE STENTS, AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE BUT IS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359437 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046630750 0031016458 08714729579656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention