BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16363391 · Received February 13, 2023

    Report

    Report Number
    3005099803-2023-00666
    Event Type
    Death
    Date Received
    February 13, 2023
    Date of Event
    June 1, 2018
    Report Date
    February 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE MONTH AND YEAR THE FIRST PROCEDURES WERE PERFORMED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORT SOURCE: LITERATURE SOURCE: BOXHOORN, L., VERDONK, R., BESSELINK, M., BOERMEESTER, M., BOLLEN, T., BOUWENSE, S., CAPPENDIJK, V., CURVERS, W., DEJONG, C., VAN DIJK, S., VAN DULLEMEN, H., VAN EIJCK, C., VAN GEENEN, E., HADITHI, M., HAZEN, W., HONKOOP, P., VAN HOOFT, J., JACOBS, M., KIEVITS, J., KOP, M., KOUW, E., KUIKEN, S., LEDEBOER, M., NIEUWENHUIJS, V., PERK, L., POLEY, JW., QUISPEL, R., DE RIDDER, R., VAN SANTVOORT, H., SPERNA WEILAND, C., STOMMEL, M., TIMMERHUIS, H., WITTEMAN, B., UMANS, D., VENNEMAN, N., VLEGGAAR, F., VAN WANROOIJ, R., BRUNO, M., FOCKENS, P., VOERMANS, R. THE DUTCH PANCREATITIS STUDY GROUP. COMPARISON OF LUMEN-APPOSING METAL STENTS VERSUS DOUBLE-PIGTAIL PLASTIC STENTS FOR INFECTED NECROTISING PANCREATITIS. BOXHOORN L, ET AL. GUT 2023: 72:66-72. DOI: 10.1136/GUTJNL-2021-325632. IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS THROUGH THE ARTICLE "COMPARISON OF LUMEN-APPOSING METAL STENTS VERSUS DOUBLE-PIGTAIL PLASTIC STENTS FOR INFECTED NECROTISING PANCREATITIS" BY DR. ROGIER P. VOERMANS, ET AL. THE STUDY COMPARED CLINICAL OUTCOMES AFTER ENDOSCOPIC TRANSLUMINAL DRAINAGE WITH LUMEN-APPOSING METAL STENTS (LAMS) AND DOUBLE PIGTAIL PLASTIC STENTS IN PATIENTS WITH INFECTED NECROTISING PANCREATITIS. ACCORDING TO THE LITERATURE, 53 PATIENTS WERE TO BE INCLUDED IN THE STUDY PERFORMED BETWEEN JUNE 01, 2018 AND MARCH 04, 2020; HOWEVER, 1 OF THE 53 PATIENTS DID NOT UNDERWENT ENDOSCOPIC TRANSLUMINAL DRAINAGE WITH LAMS BECAUSE THE NECROTIC COLLECTION COULD NOT BE VISUALIZED BY ENDOSCOPIC ULTRASOUND (EUS). TWENTY- FIVE PATIENTS WERE IMPLANTED WITH A 15MM X10MM AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM WHILE 27 PATIENTS WERE IMPLANTED WITH 20MM X10MM AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM. STUDY SHOWED 11% MORTALITY RATE IN LAMS GROUP WHILE 18% IN THE PLASTIC STENTS-GROUP. A TOTAL OF SIX PATIENTS DIED POST AXIOS STENT PLACEMENT WHILE 9 PATIENTS DIED POST PLASTIC STENT PLACEMENT. IT IS UNKNOWN WHETHER THE AXIOS STENT CONTRIBUTED OR CAUSED THE PATIENT'S DEATH. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672803 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553560

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death