BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4853031 · Received June 11, 2015

    Report

    Report Number
    3008516478-2015-00003
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    XLUMENA INC., BOSTON SCIENTIFIC CO
    Product Code
    PCU
    PMA / PMN Number
    K123250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNK. 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 BOSTON SCIENTIFIC COMPANY, THAT AN AXIOS STENT AND DELIVERY SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THERE WERE NO DEPLOYMENT ISSUES DURING RELEASE OF THE FIRST FLANGE OF THE STENT. HOWEVER, THE PHYSICIAN DID NOT LOCK THE CATHETER BEFORE BEGINNING TO DEPLOY THE SECOND STENT FLANGE. SINCE THE CATHETER WAS NOT LOCKED THE STENT WAS DEPLOYED INTO THE PSEUDOCYST WHEN THE PHYSICIAN MOVED THE DEPLOYMENT HUB ON THE HANDLE. THE PHYSICIAN COMPLETED THE PROCEDURE BY PLACING 2 DOUBLE PIGTAIL STENTS THROUGH THE CYSTGASTROSTOMY AND ADMITTED THE PT FOR OBSERVATION. REPORTEDLY, THE PHYSICIAN DIDN'T FEEL COMFORTABLE TRYING TO REMOVE THE STENT ENDOSCOPICALLY, SO THE STENT WS LEFT IN PLACE PENDING SURGERY TO REMOVE IT. THE STENT WAS REMOVED WITHOUT COMPLICATIONS DURING A LAPAROSCOPIC PROCEDURE. THE PHYSICIAN NOTED THAT THE PSEUDOCYST HAD RESOLVED COMPLETELY. THE PT HAS NOT HAD ANY COMPLICATIONS OR COMPLAINTS FOLLOWING THE REMOVAL PROCEDURE AND IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383582 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT PCU XLUMENA INC., BOSTON SCIENTIFIC CO AXS-10-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention