BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6666479 · Received June 26, 2017

    Report

    Report Number
    3005099803-2017-01848
    Event Type
    Death
    Date Received
    June 26, 2017
    Report Date
    June 2, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 02, 2017, THAT A COLD AXIOS STENT WAS IMPLANTED FOR GALLBLADDER DRAINAGE DURING A PROCEDURE IN (B)(6) 2014. REPORTEDLY THE PATIENT WAS CONSIDERED A HIGH SURGICAL RISK PATIENT. ACCORDING TO THE COMPLAINANT, FOUR DAYS AFTER AXIOS STENT PLACEMENT, THE PATIENT RECEIVED A COMPUTER TOMOGRAPHY (CT) SCAN DEMONSTRATING A BILOMA AND SHOWING THE AXIOS STENT IN THE STOMACH TOWARDS THE LEFT HEPATIC LOBE. THE PHYSICIAN REPORTED THAT IT WAS NOT POSSIBLE TO DETERMINE IF THE AXIOS STENT WAS MISPLACED (UN-NOTED AT TIME OF PLACEMENT) OR IF THE AXIOS STENT MIGRATED INTO THE STOMACH AFTER PLACEMENT. A PERCUTANEOUS DRAIN WAS PLACED TO DRAIN THE BILOMA. THE PATIENT DIED APPROXIMATELY 2 WEEKS AFTER AXIOS STENT PLACEMENT, AND THE PATIENT'S CAUSE OF DEATH IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448563 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH AXS-15-10

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death| R