BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4862989 · Received June 16, 2015

    Report

    Report Number
    3008516478-2015-00004
    Event Type
    Injury
    Date Received
    June 16, 2015
    Report Date
    May 17, 2015
    Manufacturer
    XLUMENA INC., A BOSTON SCIENTIFIC COMPANY
    Product Code
    PCU
    PMA / PMN Number
    K123250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE REPORTED EVENT OF STENT MOVED OUT OF POSITION DURING THE PROCEDURE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO XLUMENA INC, A (B)(4), THAT AN AXIOS STENT AND DELIVERY SYSTEM WAS IMPLANTED BETWEEN THE DUODENUM AND GALLBLADDER ON AN UNKNOWN DATE. THE PHYSICIAN REPORTED THAT THE INDICATION FOR THE PROCEDURE WAS AN OBSTRUCTED GALLBLADDER SECONDARY TO CANCER. THE PATIENT HAS MODERATE ASCITES. ACCORDING TO THE COMPLAINANT THAT AXIOS STENT WAS IN GOOD POSITION WHEN THE STENT WAS DEPLOYED. HOWEVER WITHIN A FEW MINUTES OF DEPLOYMENT, THE PHYSICIAN NOTED THAT THE STENT HAD MOVED OUT OF POSITION, AWAY FROM THE DUODENAL WALL. THE GUIDEWIRE WAS STILL LOCATED THROUGH THE GALLBLADDER AND THE PHYSICIAN WAS ABLE TO PLACE A 10MM BILIARY SELF EXPANDING METAL STENT FROM THE GALLBLADDER TO THE ANTRUM INSIDE THE AXIOS STENT. THE PATIENT WAS MONITORED FOR A DAY AND RELEASED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391436 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT PCU XLUMENA INC., A BOSTON SCIENTIFIC COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention