BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6333086 · Received February 15, 2017

    Report

    Report Number
    3005099803-2017-00395
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 24, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4). THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AND 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS IMPLANTED TO TREAT WALLED-OFF PANCREATIC NECROSIS (WOPN) DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2016. ON (B)(6) 2017, 61 DAYS AFTER THE STENT WAS IMPLANTED, THE PHYSICIAN ATTEMPTED TO REMOVE THE AXIOS STENT DURING A PLANNED STENT REMOVAL PROCEDURE POST-RESOLUTION OF THE PATIENT'S WOPN. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT USING A SNARE AND RAT TOOTH FORCEPS, BUT THE STENT COULD NOT BE REMOVED. THE CAUSE OF THE DIFFICULTY REMOVING WAS UNKNOWN; HOWEVER IT WAS REPORTED THAT THERE WAS POSSIBLE TISSUE INGROWTH. ON (B)(6) 2017, THE PHYSICIAN SUCCESSFULLY REMOVED THE STENT FROM THE PATIENT AND CONFIRMED THAT THE DIFFICULTY REMOVING THE STENT WAS DUE TO TISSUE INGROWTH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117311 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH M00553550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention