BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20066171 · Received August 26, 2024

    Report

    Report Number
    3005099803-2024-04022
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    January 18, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PATIENT CODE E233603 CAPTURES THE REPORTABLE EVENT OF HYPOVOLEMIC SHOCK. IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF MAJOR HEMORRHAGE. IMDRF PATIENT CODE E0301 CAPTURES THE REPORTABLE EVENT OF ANEMIA. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF MELENA. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF FIVE EPISODES OF BLEEDING WERE TREATED ENDOSCOPICALLY. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF THEIR LENGTH OF HOSPITALIZATION RANGED FROM 10 TO 22 DAYS. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF BLEEDING RESULTED IN ADMISSION TO THE INTENSIVE CARE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF COAXIAL DPPSS HAD BEEN PLACED TO PREVENT BLEEDING. IMDRF IMPACT CODE F2302 CAPTURES THE REPORTABLE EVENT OF A TWO-UNIT BLOOD TRANSFUSION WAS REQUIRED.

    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, BLEEDING OCCURRED IN NINE PATIENTS WHO HAD A HOT AXIOS STENT PLACED. FIVE OUT OF NINE OF THESE PATIENTS WERE TREATED ENDOSCOPICALLY, WHILE FOUR OF THESE PATIENTS REQUIRED EMBOLIZATION BY AN INTERVENTIONAL RADIOLOGIST. FOUR OF THESE PATIENTS REQUIRED A TWO UNIT BLOOD TRANSFUSION; TWO PRESENTED WITH HEMATEMESIS, AND TWO PRESENTED WITH HYPOVOLEMIC SHOCK, MELENA, AND ANEMIA. IN ALL FOUR OF THESE PATIENTS, BLEEDING RESULTED IN ADMISSION TO THE INTENSIVE CARE UNIT AND HOSPITALIZATION WAS PROLONGED. IN ADDITION, A PERFORATION WAS NOTED IN ONE PATIENT WHICH WAS SUCCESSFULLY CLOSED BY AN OVER-THE-SCOPE CLIP. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481944 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| H