BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19931846 · Received August 7, 2024

    Report

    Report Number
    3005099803-2024-03792
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 1, 2017
    Report Date
    August 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K220112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT EVENT DATE IS UNKNOWN; EVENT OCCURRED BETWEEN JUNE 2017 AND DECEMBER 2020. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: JOAN B. GORNALS ET AL. PLASTIC PIGTAIL VS LUMEN-APPOSING METAL STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS (PROMETHEUS STUDY): AN OPEN-LABEL, MULTICENTER RANDOMIZED TRIAL. SURGICAL ENDOSCOPY (2024) 38:2148- 2159. HTTPS://DOI.ORG/10.1007/S00464-024-10699-W. BLOCK H6: IMDRF DEVICE CODE A22 CAPTURES THE REPORTABLE EVENT OF STENT OVERGROWTH IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF STENT DIFFICULT TO REMOVE IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION PERFORMED TO REMOVE THE STENT.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS AND ADVANIX DOUBLE PIGTAIL PLASTIC STENTS THROUGH THE ARTICLE "PLASTIC PIGTAIL VS LUMEN-APPOSING METAL STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS (PROMETHEUS STUDY): AN OPEN-LABEL, MULTICENTER RANDOMIZED TRIAL" BY JOAN B. GORNALS, ET AL. PER THE ARTICLE, BETWEEN JUNE 2017 AND OCTOBER 2020 THE FOLLOWING OCCURRED WITH STUDY PATIENTS: STENT DYSFUNCTIONS, INCLUDING TECHNICAL FAILURE, TECHNICAL DIFFICULTIES AND OVERGROWTH. ADDITIONALLY, SOME PATIENTS EXPERIENCED BLEEDING, PSEUDOANEURYSMS, RECURRENCES, FEVER, SUSPECTED PERFORATION AND OTHER STENT RELATED ADVERSE EVENTS. THE STENT DYSFUNCTIONS AND PATIENT COMPLICATIONS REPORTED WERE MANAGED THROUGH REMOVAL OF THE STENT, HOSPITALIZATION OR PROLONGED HOSPITALIZATION, SURGERY AND ADMISSION TO THE INTENSIVE CARE UNIT. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234707 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention