BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 11815833 · Received May 12, 2021

    Report

    Report Number
    3005099803-2021-02167
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904588
    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

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED; 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 IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING A PANCREATIC PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT EXPERIENCED HEARTBURN. AN ENDOSCOPY PROCEDURE WAS PERFORMED AND IT WAS NOTED THAT THE STENT MIGRATED INTO THE LOWER DIGESTIVE TRACT. ONE OF THE STENT FLANGE'S PERFORATED THE DESCENDING COLON AND FECAL JUICE WAS OBSERVED IN THE STOMACH. THE STENT WAS REMOVED FROM THE PATIENT USING A SNARE. THE PERFORATION WAS CLOSED USING AN ENDOSCOPIC CLIP AND THE PUNCTURE SITE WAS ALSO CLOSED. THE PROCEDURE WAS COMPLETED WITHOUT IMPLANTING A NEW DEVICE. IN THE PHYSICIAN'S ASSESSMENT, THERE WAS A RELATIONSHIP BETWEEN THE HEARTBURN, PERFORATION AND THE AXIOS STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708794 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553640 0026142092 08714729904588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention