BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19917327 · Received August 6, 2024

    Report

    Report Number
    3005099803-2024-03663
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    December 15, 2022
    Report Date
    August 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904595
    PMA / PMN Number
    K233318
    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 LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER ADDRESS: 6-7-1 NISHISHINJUKU, SHINJUKU-KU. BLOCK G2: LITERATURE SOURCE: YI-JUN LIAO, RYOSUKE TONOZUKA, AND TAKAO ITOI. "RETRIEVAL OF A MISDEPLOYED LUMEN-APPOSING METAL STENT IN WALLED-OFF NECROSIS BY A PARALLEL WITHDRAWAL TECHNIQUE USING A DOUBLE-CHANNEL ENDOSCOPE" DIGESTIVE ENDOSCOPY (2023) 35: E41-E43. DOI: 10.1111/DEN.14501. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF STENT DIFFICULT TO REMOVE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF STENT WAS REMOVED USING TOW ALLIGATOR FORCEPS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THAT INVOLVE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH AN ARTICLE TITLED, "RETRIEVAL OF A MISDEPLOYED LUMEN-APPOSING METAL STENT IN WALLED-OFF NECROSIS BY A PARALLEL WITHDRAWAL TECHNIQUE USING A DOUBLE-CHANNEL ENDOSCOPE", BY YI-JUN LIAO ET AL. A RETROSPECTIVE STUDY WAS CONDUCTED ON A PATIENT WITH EPIGASTRIC PAIN AND FEVER FOR 2 WEEKS. A 15MM AXIOS STENT WAS USED. HOWEVER, THE STENT MIGRATED INTO THE WON CAVITY DURING DEPLOYMENT. RETRIEVAL OF THE MISDEPLOYED 15MM STENT WAS UNSUCCESSFUL AND AN ADDITIONAL 20MM AXIOS STENT WAS DEPLOYED. HOWEVER, SEVEN DAYS POST STENT PLACEMENT, A FORWARD-VIEWING ENDOSCOPE WAS INSERTED THROUGH THE 20MM STENT AND IT WAS OBSERVED THAT THE MISDEPLOYED 15MM STENT WAS BLOCKED BY NECROTIC TISSUE. THE STENT WAS DIFFICULT TO REMOVE AS THERE WAS LIMITED SPACE TO OPEN A SNARE TO EXTRACT THE MISDEPLOYED STENT. THE MIGRATED 15MM AXIOS STENT WAS EVENTUALLY REMOVED USING TWO ALLIGATOR FORCEPS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841584 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553650 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention