BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20010217 · Received August 21, 2024

    Report

    Report Number
    3005099803-2024-03943
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    January 1, 2023
    Report Date
    August 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE 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: NAO FUJIMORI ET. AL. "STENTING BIBLE RENEWAL; FOCUS ON STENTING AND INSERTION AND PLACEMENT PROCEDURES; STENTING STRATEGIES FOR INFLAMMATION AND FLUID RETENTION; STENTING STRATEGIES FOR POSTOPERATIVE PANCREATIC FISTULA" BILIARY AND PANCREATIC PROVISIONAL SPECIAL ISSUE 2023; 44: 1215-1221. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT BLOCKED/OCCLUDED. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF ABDOMINAL PAIN. IMDRF PATIENT CODE E230101 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF FEVER. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF ABSCESS. IMDRF IMPACT CODE F08 CAPTURES THE PATIENT'S HOSPITAL RE-ADMISSION. IMDRF IMPACT CODE F2301 CAPTURES THE ADDITIONAL DEVICE USED FOR ENDOSCOPIC STENT REPLACEMENT. IMDRF IMPACT CODE F2202 CAPTURES THE ENDOSCOPIC STENT REPLACEMENT.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE TITLED, "STENTING BIBLE RENEWAL; FOCUS ON STENTING AND INSERTION AND PLACEMENT PROCEDURES; STENTING STRATEGIES FOR INFLAMMATION AND FLUID RETENTION; STENTING STRATEGIES FOR POSTOPERATIVE PANCREATIC FISTULA", BY NAO FUJIMORI ET. AL. PER THE ARTICLE, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND FEVER. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE STENT HAD NOT SHIFTED FROM ITS ORIGINAL POSITION. DESPITE THIS, THE PATIENT'S CONDITION DID NOT IMPROVE, LEADING TO A READMISSION TO THE HOSPITAL. FURTHER ENDOSCOPIC AND FLUOROSCOPIC IMAGING REVEALED THAT THE STENT OPENING WAS OBSTRUCTED BY RESIDUAL FOOD AND FLUID. CATHETERIZATION SUCCESSFULLY DRAINED PURULENT FLUID. A DOUBLE-PIGTAILED PLASTIC STENT AND AN ENDOSCOPIC NASOBILIARY DRAINAGE TUBE (ENBD) WERE INSERTED THROUGH THE AXIOS STENT. THE PATIENT'S CONDITION SUBSEQUENTLY IMPROVED, AND THE POPF DIMINISHED, ALLOWING FOR THE EVENTUAL REMOVAL OF THE AXIOS STENT. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153375 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H