BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20069780 · Received August 26, 2024

    Report

    Report Number
    3005099803-2024-04028
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    January 18, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. APPROXIMATED BASED ON THE DATE THE ARTICLE WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: BENEDETTO MANGIAVILLANO ET AL. "LUMEN-APPOSING METAL STENTS FOR THE TREATMENT OF PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS AND BLEEDING RISK: A PROPENSITY MATCHED STUDY" ENDOSCOPY 2024; 56: 249-257 DOI: HTTPS://DOI.ORG/10.1055/A-2219-3179. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE "LUMEN APPOSING METAL STENTS FOR THE TREATMENT OF PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS AND BLEEDING RISK: A PROPENSITY MATCHED STUDY." BY BENEDETTO MANGIAVILLANO ET AL. PER THE ARTICLE, A RETROSPECTIVE STUDY INCLUDED PATIENTS WITH SYMPTOMATIC PANCREATIC FLUID COLLECTIONS (PFCS) WHO UNDERWENT ENDOSCOPIC ULTRASOUND (EUS)-GUIDED DRAINAGE USING HOT AXIOS OR HOT SPAXUS FROM JULY 10, 2019 TO FEBRUARY 28, 2022. A TOTAL OF 185 PATIENTS UNDERWENT PLACEMENT OF HOT AXIOS AT ONE OF 18 HIGH VOLUME ENDOSCOPY REFERRAL CENTERS. TECHNICAL AND CLINICAL SUCCESS RATES WERE SIMILAR BETWEEN THE HOT AXIOS AND HOT SPAXUS GROUP. POST STENT PLACEMENT, TWO STENT MIGRATIONS WERE NOTED AT 32 AND 45 DAYS. THE MIGRATED STENTS WERE NOT REPLACED AS THERE WAS A HEALING SIGN. THERE WERE ALSO TWENTY LAMS OCCLUSION NOTED. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280187 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