BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 7251403 · Received February 8, 2018

    Report

    Report Number
    2134265-2018-01166
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    January 31, 2018
    Report Date
    January 31, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2018-01134. IT WAS REPORTED THAT EMBOLIZATION OCCURRED POST PROCEDURE. A DEEP VEIN THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL VEIN (SFV) WAS COMPLETED USING AN ANGIOJET ZELANTEDVT WITHOUT ISSUE WITH A RUN TIME OF 480 SECONDS. A WALLSTENT WAS SUBSEQUENTLY IMPLANTED. AN UNCLEAN SUBSTANCE EMBOLIZED THE DAY AFTER THE PROCEDURE IN THE WALLSTENT. THE CAUSE OF THE EMBOLISM WAS UNKNOWN BY THE PHYSICIAN. AN ADDITIONAL ANGIOJET THROMBECTOMY PROCEDURE WAS COMPLETED AND THE ISSUE RESOLVED. THE PATIENT WAS PLACED UNDER OBSERVATION AND WAS NOTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100636 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention