BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 11794087 · Received May 7, 2021

    Report

    Report Number
    3005099803-2021-02076
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 7, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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 IN A TRANSGASTRIC POSITION TO TREAT PANCREATIC PSEUDOCYST DURING A CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2021. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE STENT PREMATURELY DEPLOYED IN THE STOMACH AT "STEP 4". THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITHOUT USING ANOTHER DEVICE. 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
    690936 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553650 0025821029 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention