BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 7126554 · Received December 18, 2017

    Report

    Report Number
    3005099803-2017-03739
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Report Date
    November 23, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; 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 THAT A HOT AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A 15 CM PANCREATIC FLUID COLLECTION (PFC) WITH 20% NECROSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE STENT WAS VISIBLE ON A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED THREE WEEKS AFTER THE AXIOS STENT WAS IMPLANTED. HOWEVER, DURING AN UPPER GASTROINTESTINAL ENDOSCOPY FOR STENT REMOVAL 32 DAYS POST-IMPLANTATION, THE AXIOS STENT WAS NOTED TO HAVE MIGRATED. REPORTEDLY, THE PATIENT'S PFC HAD RESOLVED AT THE TIME OF THE REMOVAL PROCEDURE. THE PHYSICIAN EXPECTS THE STENT TO PASS NATURALLY, AND THE PATIENT HAS NOT HAD ANY COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE ASYMPTOMATIC WITHOUT RECURRENCE OF THEIR PFC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903796 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553560

    Patients

    Seq Age Sex Outcome Treatment
    1