BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4293957 · Received October 14, 2014

    Report

    Report Number
    3008516478-2014-00002
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    XLUMENA INC.
    Product Code
    PCU
    PMA / PMN Number
    K123250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD COPIOUS AMOUNTS OF NECROTIC PANCREATITIC TISSUE. THIS WAS THE PHYSICIANS FIRST CASE AFTER TRAINING TO THE USE OF THE AXIOS DEVICE. THE DEVICE DID NOT DEMONSTRATE OBVIOUS MALFUNCTION AND WAS LIKELY DEPLOYED INCORRECTLY WITHIN THE GASTROSTOMY TRACT. THE PROXIMAL FLANGE, CAUGHT WITHIN THE TRACT, MOVED THE STENT FORWARD INTO THE PSEUDOCYST.

    Description of Event or Problem · 1

    PT WITH A ALCOHOLIC PANCREATITIS WITH SUBSEQUENT PANCREATIC NECROSIS AND PSEUDOCYST FORMATION HAD AN ATTEMPTED AXIOS STENT PLACEMENT FOR PSEUDOCYST DRAINAGE OF A MODERATE SIZED PSEUDOCYST. THE DISTAL END (FLANGE) OF THE STENT WAS DEPLOYED. THE PROXIMAL END (FLANGE) WAS DEPLOYED BUT DID NOT APPEAR AS EXPECTED WITH ONLY 8-9MM OF THE FLANGE VISIBLE ENDOSCOPICALLY. THE PHYSICIAN INITIALLY THOUGH THAT THE STENT WAS TOO SHORT. THE STENT DISPLACED AND MOVED FORWARD INTO THE PSEUDOCYST. THE PHYSICIAN DILATED THE TRACT USING A 15MM CRE BALLOON AND REMOVED THE STENT USING FORCEPS UNDER ENDOSCOPIC GUIDANCE. THE TRACT WAS CLOSED USING AN OVERSCO OTS CLIP. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELA. SEVERAL DAYS LATER, THE PATIENT HOSE ELECTIVELY TO HAVE THE PSEUDOCYST SURGICALLY DRAINED. SURGERY FOUND COPIOUS AMOUNTS OF NECROTIC PANCREATIC TISSUE ASSOCIATED WITH THE DISEASE PROCESS. THE POST-OPERATIVE COURSE WAS COMPLEX DUE TO THE NECROTIC PANCREATITIS BUT THE PATIENT HAS SINCE BEEN DISCHARGED HOME TO COMPETE FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652043 AXIOS STENT AND DELIVERY SYSTEM AXIOS STENT PCU XLUMENA INC. AXS-15-10

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR 15MM CRE BALLOON| ENDOSCOPE| FORCEPS| OVESCO OTS CLIP