BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19503329 · Received June 10, 2024

    Report

    Report Number
    3005099803-2024-02751
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    January 18, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. LITERATURE SOURCE: MANGIAVILLANO BENEDETTO 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 10.1055/A-2219-3179. BLOCK H6: IMDRF PATIENT CODE E233603 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF SEPTIC SHOCK. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BLEEDING. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERFORATION. IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF VOMITING. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF MELENA (BLOOD IN THE STOOL). IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OCCLUSION. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL INTERVENTION OF ANOTHER ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F08 CAPTURES PATIENT PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F23 CAPTURES THE ADDITIONAL INTERVENTION OR ARTERIAL EMBOLIZATION. IMDRF IMPACT CODE F0801 CAPTURES THE INTENSIVE CARE UNIT. IMDRF IMPACT CODE F2301 CAPTURES THE ADDITIONAL DEVICE REQUIRED TO COMPLETE THE PROCEDURE. IMDRF IMPACT CODE F2302 CAPTURES THE ADDITIONAL INTERVENTION OF BLOOD TRANSFUSION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DIFFERENT SIZED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM DEVICES REFERENCED IN THE ARTICLE. PLEASE REFER TO MANUFACTURER'S REF # 3005099803-2024-02748 FOR THE 10X10 MM, MANUFACTURER'S REF., FOR THE 15X10 MM, AND MANUFACTURER'S REF # 3005099803-2024-02745 FOR THE 20X10 MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THAT INVOLVE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM DEVICES THROUGH AN ARTICLE TITLED, "LUMEN-APPOSING METAL STENTS FOR THE TREATMENT OF PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS AND BLEEDING RISK: A PROPENSITY MATCHED STUDY", BY MANGIAVILLANO BENEDETTO ET AL. THE STUDY AIMS TO COMPARE THE RATES OF BLEEDING BETWEEN THE AXIOS STENT AND A COMPETITOR DEVICE. A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS WHO PRESENTED WITH SYMPTOMATIC PANCREATIC FLUID COLLECTION (PFC) AND WERE TREATED USING COLD OR HOT LUMEN-APPOSING METAL STENTS (LAMS) (HOT-AXIOS OR SPAXUS/HOT-SPAXUS) FROM JULY 10, 2019, TO FEBRUARY 28, 2022, AT ONE OF THE 18 HIGH VOLUME ENDOSCOPY REFERRAL CENTERS. ACCORDING TO THE LITERATURE, 363 PATIENTS WERE EVALUATED. AFTER A 1-TO-1 PROPENSITY SCORE MATCH, 264 PATIENTS WERE SELECTED (132 PER GROUP). THE PROCEDURE WAS PERFORMED USING EITHER THE FREEHAND TECHNIQUE OR 19G FINE NEEDLE ASPIRATION (FNA) NEEDLE PUNCTURE OF THE TARGET PFC, FOLLOWED BY GUIDEWIRE PLACEMENT, CYSTOTOME USE, AND LAMS PLACEMENT. DISTAL FLANGE RELEASE WAS PERFORMED UNDER EUS CONTROL IN ALL CASES, WHEREAS THE PROXIMAL FLANGE WAS DELIVERED USING THE "INTRA-CHANNEL RELEASE" TECHNIQUE OR UNDER ENDOSCOPIC/FLUOROSCOPIC VIEW. STUDY OUTCOMES REPORTED NINE BLEEDS REQUIRING TRANSFUSION AND/ OR INTERVENTION IN THE HOT AXIOS GROUP. THE STENTS PLACED AMONG THE PATIENTS WHO EXPERIENCED BLEEDING REQUIRING TRANSFUSION AND/ OR INTERVENTION IN THE HOT-AXIOS GROUP WERE A 10X10-MM STENT (N=1) (MANUFACTURER'S REF # 3005099803-2024-02748), A 15X10-MM (N=5) (SUBJECT OF THIS REPORT), AND A 20X10-MM (N=3) (MANUFACTURER'S REF # 3005099803-2024-02745). BLEEDING OCCURRED EARLY (WITHIN 24 HOURS) IN TWO PATIENTS, WHILE TWO OTHERS BLED AT 48 HOURS; THE REMAINING FIVE PATIENTS BLED LATE AT 12, 16, 18, 21, AND 23 DAYS. FIVE EPISODES OF BLEEDING OCCURRED AT THE SITE OF LAMS PLACEMENT AND WERE TREATED ENDOSCOPICALLY, WHILE IN FOUR PATIENTS (3.0%), BLEEDING OCCURRED INSIDE THE CAVITY AND REQUIRED EMBOLIZATION BY AN INTERVENTIONAL RADIOLOGIST. IN ALL FOUR OF THESE PATIENTS, A TWO-UNIT BLOOD TRANSFUSION WAS REQUIRED; TWO PRESENTED WITH HEMATEMESIS AND TWO WITH HYPOVOLEMIC SHOCK AND MELENA, AND THEIR MEAN (SD) HEMOGLOBIN DROP WAS OF 4.8 (1.2) G/DL. FOR ALL FOUR OF THEM, BLEEDING RESULTED IN ADMISSION TO THE INTENSIVE CARE UNIT FOR 2 NIGHTS, AND THEIR LENGTH OF HOSPITALIZATION RANGED FROM 10 TO 22 DAYS. TWO OF THESE PATIENTS, COAXIAL DOUBLE PIGTAIL PLASTIC STENT HAD BEEN PLACED TO PREVENT BLEEDING. FINALLY, ONE CASE OF MODERATE BLEEDING DURING HOT- AXIOS STENT PLACEMENT WAS ALSO OBSERVED. THERE WERE THREE ADDITIONAL ADVERSE EVENTS; ONE PROCEDURAL PERFORATION WAS SUCCESSFULLY CLOSED BY AN OVER-THE-SCOPE CLIP AND TWO MIGRATED STENTS WERE NOT REPLACED AT 32 AND 45 DAYS BECAUSE OF A HEALING SIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666094 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R