BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20150026 · Received September 5, 2024

    Report

    Report Number
    3005099803-2024-04268
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    January 1, 2015
    Report Date
    September 5, 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. THE RETROSPECTIVE STUDY DATE OF JANUARY 2015 IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: M AMATA, D SCIMECA, F MOCCIARO, B SCRIVO, E CONTE, A BOFIACCORSO, A CALI, S SFERRAZZA, V DI MARTINO, R DI MITRI. "EUS-GUIDED BILIARY DRAINAGE WITH FC-SEMS AND LAMS IN DISTAL MALIGNANT BILIARY OBSTRUCTION AFTER ERCP FAILURE: RETROSPECTIVE ANALYSIS OF 8-YEARS' CUMULATIVE EXPERIENCE IN A SICILIAN REFERRAL TERTIARY-CARE CENTER FOR BILIOPANCREATIC DISEASE." ABSTRACTS OF THE 30TH NATIONAL CONGRESS OF DIGESTIVE DISEASES/DIGESTIVE AND LIVER DISEASE 56S2 2024: S181-S182. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF MALDEPLOYED STENT. IMDRF IMPACT CODE F2202 CAPTURES THE PERCUTANEOUS-TRANSHEPATIC-ENDOSCOPIC-RENDEZVOUS (PTER) AND LAPAROSCOPIC-ENDOSCOPIC-RENDEZVOUS (LER). IMDRF IMPACT CODE F23 CAPTURES THE RESCUE THERAPY (RT) BY ENDOSCOPIC PLACEMENT OF FC-SEMS. IMDRF IMPACT CODE F2301 CAPTURES THE ENDOSCOPIC PLACEMENT OF FC-SEMS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE, "EUS-GUIDED BILIARY DRAINAGE WITH FC-SEMS AND LAMS IN DISTAL MALIGNANT BILIARY OBSTRUCTION AFTER ERCP FAILURE: RETROSPECTIVE ANALYSIS OF 8-YEARS' CUMULATIVE EXPERIENCE IN A SICILIAN REFERRAL TERTIARY-CARE CENTER FOR BILIOPANCREATIC DISEASE," BY M. AMATA, ET AL. THE ARTICLE DESCRIBES A SINGLE-CENTER, RETROSPECTIVE STUDY CONDUCTED AT A.R.N.A.S. CIVICO DI CRISTINA -BENFRATELLI HOSPITAL BETWEEN JANUARY 2015 TO DECEMBER 2022. THE STUDY RETROSPECTIVELY INCLUDED ALL CASES OF ENDOSCOPIC ULTRASOUND-GUIDED BILIARY DRAINAGE (EUS-BD) PERFORMED FOR BILIARY DECOMPRESSION IN PATIENTS WITH UNRESECTABLE DISTAL MALIGNANT BILIARY OBSTRUCTION (D-MBO) WHO HAD UNSUCCESSFUL ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). A FULLY COVERED SELF-EXPANDABLE METAL STENT (FC-SEMS) WAS DEPLOYED USING A MULTISTEP APPROACH, AND A LUMEN APPOSING METAL STENT (LAMS) WAS DEPLOYED USING A "FREE-HAND," "SINGLE-STEP," AND "EXCHANGE-FREE" TECHNIQUE. THE PRIMARY OUTCOMES MEASURED WERE TECHNICAL AND CLINICAL SUCCESS. A TOTAL OF 75 EUS-BD PROCEDURES WERE REVIEWED, INCLUDING EIGHT CHOLEDOCHO-DUODENOSTOMIES (CDS) WITH FC-SEMS, 58 CDS WITH HOT AXIOS, ONE CDS WITH HOT-SPAXUS, AND EIGHT CHOLECYSTO-GASTROSTOMIES WITH HOT AXIOS. DURING EUS-CDS, THERE WERE A TOTAL OF EIGHT HOT AXIOS MALDEPLOYMENT CASES. THESE WERE MANAGED WITH RESCUE THERAPY (RT) BY ENDOSCOPIC PLACEMENT OF FC-SEMS IN SIX OF THE EIGHT CASES, USING PERCUTANEOUS-TRANSHEPATIC-ENDOSCOPIC-RENDEZVOUS IN ONE CASE, AND LAPAROSCOPIC-ENDOSCOPIC-RENDEZVOUS IN THE REMAINING CASE. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS. DESPITE FURTHER EFFORTS TO CONFIRM THE EXACT LOCATIONS OF THE DEVICES, NO RESPONSES WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035634 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION UNK-P-HOT_AXIOS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention