BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4053444 · Received July 29, 2014

    Report

    Report Number
    3008516478-2014-00005
    Event Type
    Other
    Date Received
    July 29, 2014
    Date of Event
    June 21, 2014
    Report Date
    July 16, 2014
    Manufacturer
    XLUMENA, INC.
    Product Code
    PCU
    PMA / PMN Number
    K140561
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURER'S INVESTIGATION, BLEEDING WAS CAUSED BY THE STENT LOCATED TOO CLOSE TO THE GASTRODUODENAL ARTERY AND DURING RESOLUTION OF THE PSEUDOCYST, THE CYST COLLAPSED ON THE FLANGE OF THE AXIOS WITH EROSION OF THE ARTERY. THERE WAS NO REPORT OF DEVICE MALFUNCTION. REVIEW OF THE PRODUCT LABELING NOTES A WARNING RELATED TO EXCESSIVE BLEEDING (REQUIRING INTERVENTION), WHICH IS A KNOWN POTENTIAL RISK OF ENDOSCOPIC STENTING/DRAINAGE. IDENTIFICATION OF INTERVENING VESSELS PRIOR TO STENT PLACEMENT IS STANDARD PRACTICE FOR ENDOSCOPIC PROCEDURES. THIS COMPLICATION IS A KNOWN RISK OF ENDOSCOPIC STENTING/PROCEDURES.

    Description of Event or Problem · 1

    PATIENT (MALE (B)(6) YEAR OLD) UNDERWENT UNEVENTFUL PANCREATIC PSEUDOCYST DRAINAGE WITH THE AXS-15-10 STENT. APPROXIMATELY TWO DAYS POST PROCEDURE, PATIENT DEVELOPED A PSEUDOANEURYSM WHICH REQUIRED EMBOLIZATION TO CONTROL BLEEDING AND NECROSECTOMY OF THE CYST TO REMOVE CLOT. THE PHYSICIAN STATED THAT THE CYST COLLAPSED ON THE INNER FLANGE OF THE AXIOS AND APPEARS TO HAVE ERODED INTO THE GASTRODUODENAL ARTERY. THE AXIOS STENT WAS REMOVED ON POD 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443108 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT AND DELIVERY SYSTEM PCU XLUMENA, INC. AXS-15-10 FGS00175

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other NONE REPORTED