BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4643341 · Received March 27, 2015

    Report

    Report Number
    3008516478-2015-00001
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 27, 2015
    Manufacturer
    XLUMENA INC.
    Product Code
    PCU
    PMA / PMN Number
    K123250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STENT LOCATION OF PLACEMENT IN THE STOMACH IS BELIEVED TO BE A FACTOR IN THE OPINION OF THE TREATING PHYSICIAN. THE STENT WAS PLACED IN THE DEPENDENT PORTION OF THE STOMACH WHERE FOOD TYPICALLY COLLECTS.

    Description of Event or Problem · 1

    THE ACTUAL IMPLANT DATE IS NOT KNOWN. WHEN THE INITIAL PSEUDOCYST WAS DRAINED IT WAS CLEAR LIQUID AND NOT INFECTED. IT BECAME INFECTED APPROXIMATELY 3 WEEKS AFTER PLACEMENT. A SUBSEQUENT ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED. THE STENT WAS FOUND IN PLACE AND APPEARED TO BE OCCLUDED WITH FOOD DEBRIS. THE PSEUDOCYST WAS DRAINED, VIGOROUSLY IRRIGATED WITH NORMAL SALINE AND THE AXIOS STENT REMOVED. PLASTIC STENTS AND A NASOCYSTIC DRAIN WERE PLACED. THERE WERE NO COMPLICATIONS DURING THIS PROCEDURE AND THE PT DID WELL AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205122 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT PCU XLUMENA INC. AXS-10-10 FGS00187

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention