BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 22005537 · Received May 12, 2025

    Report

    Report Number
    3005099803-2025-02069
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    February 1, 2019
    Report Date
    May 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF FEBRUARY 1, 2019, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN FEBRUARY 2019 AND SEPTEMBER 2024. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER ADDRESS 1: (B)(6); REPORTED HERE AS THE ADDRESS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: DONATELLI, G., ET AL. "FIRST INTENTION EUS GUIDED TRANSLUMINAL DRAINAGE WITH LAMS: AN EFFECTIVE AND SAFE METHOD FOR MANAGEMENT OF FLUID COLLECTIONS AFTER ANY KIND OF SURGERY" SURGICAL ENDOSCOPY (2025) 39:2415 2424; DOI. ORG/ 10. 1007/S00464- 025- 11615-6. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT MISDEPLOYMENT. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OCCLUSION. IMDRF PATIENT CODE E2314 CAPTURES THE REPORTABLE EVENT OF A CHRONIC FISTULA. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF INTRABDOMINAL ABSCESS. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC DEBRIDEMENT. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF ANTIBIOTIC ADMINISTRATION. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL TREATMENT FOR THE FISTULA. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CROSSECTIONAL IMAGING. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF AN ADDITIONAL STENT WAS PLACED. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF RADIOLOGIC DRAINAGE WAS PERFORMED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE "FIRST INTENTION EUS GUIDED TRANSLUMINAL DRAINAGE WITH LAMS: AN EFFECTIVE AND SAFE METHOD FOR MANAGEMENT OF FLUID COLLECTIONS AFTER ANY KIND OF SURGERY", BY DONATELLI, G., ET AL. PER THE ARTICLE, A MONOCENTRIC RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS WITH SYMPTOMATIC POSTOPERATIVE COLLECTIONS (PCS) BETWEEN FEBRUARY 2019 AND SEPTEMBER 2024. THE STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF POSTOPERATIVE COLLECTIONS (EUS-PCD) AS A FIRST-LINE APPROACH FOR ALL TYPES OF PCS. THE ARTICLE REPORTS THE FOLLOWING OUTCOMES FOR THE STUDY PATIENTS: TWO CASES IN WHICH STABLE POSITIONING OF THE ENDOSCOPE COULD NOT BE ACHIEVED DUE TO FACTORS RELATED TO THE PATIENT'S ANATOMY OR CLINICAL SITUATION. BOTH PATIENTS WERE REFERRED FOR RADIOLOGIC DRAINAGE. ONE CASE OF STENT MISDEPLOYMENT DURING THE PROCEDURE, WHICH DID NOT REQUIRE INTERVENTION. THREE CASES OF RECURRENT PCS AFTER STENT REMOVAL, WHICH WERE RE-TREATED WITH EUS-PCD. TWO CASES OF CHRONIC FISTULAS, ONE TREATED WITH ENDOSCOPIC CLOSURE AND THE OTHER REQUIRING SURGERY. TWO CASES OF STENT OCCLUSION, WHICH REQUIRED EARLY ENDOSCOPIC DEBRIDEMENT. ONE CASE OF A SMALL INTRA-ABDOMINAL ABSCESS, WHICH WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600184 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