BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 11635374 · Received April 8, 2021

    Report

    Report Number
    3005099803-2021-01474
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904595
    PMA / PMN Number
    K153088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER CITY, PROVINCE AND ZIP CODE: (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED 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 (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PANCREATIC PSEUDOCYST DURING A PANCREATIC CYST GASTRIC BYPASS PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT GOT CAUGHT ON THE DELIVERY SYSTEM AND WAS MOVED FROM THE CORRECT POSITION INTO THE STOMACH. THE STENT WAS REMOVED USING A SNARE AND ANOTHER AXIOS STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531694 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553650 0026633676 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention