BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4254331 · Received November 12, 2014

    Report

    Report Number
    3008516478-2014-00003
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 10, 2014
    Report Date
    November 10, 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

    PHYSICIAN REPORTED THAT THE PATIENT DID NOT HAVE ANY COMPLICATIONS. ALTHOUGH THERE WAS NO PATIENT INJURY THERE IS A RISK THAT ONE COULD OCCUR. THIS WAS AN OFF-LABEL USE CASE. THE AXIOS IS NOT INDICATED FOR GALLBLADDER USE. THE PHYSICIAN WAS NOTIFIED IN WRITING THAT XLUMENA DOES NOT PROMOTE NOR SUPPORT THE USE OF ITS PRODUCTS FOR USES OUTSIDE OF THE LEGAL AND CLEARED INDICATIONS. WE CONSEQUENTLY CANNOT GUARANTEE THE PERFORMANCE OR SAFETY OF OUR PRODUCTS WHEN THEY ARE USED FOR APPLICATIONS THAT HAVE NOT BEEN LEGALLY CLEARED AND REVIEWED FOR COMMERCIALIZATION. IN SUM, WE CAN MAKE NO CLAIMS REGARDING THE USE OF THE AXIOS STENT AND DELIVERY SYSTEM FOR GALLBLADDER APPLICATIONS AND, AS INDICATED EARLIER, CANNOT SUPPORT ITS USE FOR THESE PURPOSES.

    Description of Event or Problem · 1

    THE FIRST FLANGE OF THE AXIOS STENT WAS DEPLOYED WITHOUT INCIDENT. THE PHYSICIAN CHOSE TO USE ENDOSCOPIC ULTRASOUND IMAGING TO DEPLOY THE SECOND FLANGE SINCE THE ENDOSCOPE WAS IN AN UNSTABLE POSITION TO ATTEMPT TO PULL BACK AND USE AN ENDOSCOPIC VIEW. HE OPENED THE CATHETER LOCK AND SNUGGED THE FIRST FLANGE TO THE GALLBLADDER WALL, PULLING IT TO THE TRANSDUCER. HE THEN DEPLOYED THE SECOND FLANGE INSIDE THE ENDOSCOPE WORKING CHANNEL AND PUSHED THE SECOND FLANGE OUT USING THE CATHETER. UPON REGAINING THE ENDOSCOPIC VIEW, IT WAS IMPOSSIBLE TO SEE THE SECOND FLANGE. ENDOSCOPIC ULTRASOUND CONFIRMED THAT IT WAS BELOW THE MARGIN OF THE DUODENUM. BILE FLOW WAS SEEN, CONTRAST INJECTED WITHOUT EVIDENCE OF LEAKAGE. ON A FOLLOW-UP EMAIL THE PHYSICIAN STATED THAT "PATIENT HAD SOME PAIN AFTER THE PROCEDURE WHICH IS EXPECTED...LIKELY SOME BILE PERITONITIS DOING BETTER. THE PROCEDURE WAS 20 MINUTES LONGER ASSOCIATED WITH THE INSERTION OF THE WALLFLEX STENT. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729596 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT PCU XLUMENA INC. 3008516478201400003

    Patients

    Seq Age Sex Outcome Treatment
    1