BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA ICE PLUS - PI

    MDR report key: 9105396 · Received September 23, 2019

    Report

    Report Number
    2134265-2019-11532
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    August 29, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXK
    PMA / PMN Number
    K181042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED RESULTING IN STENT MIGRATION REQUIRING ADDITIONAL INTERVENTION. A 16 X 90 X 100 VICI SELF EXPANDING STENT WAS SELECTED FOR A LEFT COMMON ILIAC STENTING PROCEDURE. THE NON-THROMBOTIC SECTION TO BE TREATED WAS 20-30 MM. DURING THE PROCEDURE, THE STENT WAS IMPLANTED WITH NO COMPLICATIONS. THE LEADING EDGE OF THE STENT WAS PLACED IN THE PROXIMAL LCIV AND EXTENDED TO PROXIMAL LEIV. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE MULTIPLE CATHETERS INTO THE STENT AND WAS MET WITH RESISTANCE AT THE PROXIMAL OSTIUM OF THE STENT. WHEN THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE ULTRA ICE CATHETER INTO THE STENT TO VISUALIZE IT, THE VESSEL WAS SO TORTUOUS THAT THE CATHETER PUSHED AGAINST THE END OF THE STENT AND IT DISLODGED FROM WHERE IT WAS ORIGINALLY IMPLANTED. THE LEADING EDGE OF THE STENT WAS NOW IN THE DISTAL IVC EXTENDING INTO THE LCIV. A BALLOON WAS USED TO PULL THE STENT DOWN AND AN APPOSING STENT WAS PLACED FROM THE DISTAL IVC INTO THE RIGHT CIV AND THE STENT ON THE LEFT WAS EXTENDED INTO THE LEIV. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900123 ULTRA ICE PLUS - PI CATHETER, ULTRASOUND, INTRAVASCULAR DXK BOSTON SCIENTIFIC CORPORATION 1816-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention