BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16364347 · Received February 13, 2023

    Report

    Report Number
    3005099803-2023-00704
    Event Type
    Injury
    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
    K150692
    Adverse Event
    Yes
    Product Problem
    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. 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. PATIENT CODE E2402 CAPTURES THE REPORTABLE EVENT OF NEW-ONSET ORGAN FAILURE. PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE, MAJOR. PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INFECTION. IMPACT CODE F2302 CAPTURES THE REPORTABLE INTERVENTION OF BLOOD TRANSFUSION. IMPACT CODE F19 CAPTURES THE SURGICAL INTERVENTION TO MANAGE THE BLEEDING. IMPACT CODE F08 CAPTURES THE PATIENT'S HOSPITAL ADMISSION BEYOND THE STANDARD OF CARE. IMPACT CODE F2301 CAPTURES THE REPORTABLE INTERVENTION OF PERCUTANEOUS CATHETER DRAINAGE. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    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. ON AN UNKNOWN DATE, 9 PATIENTS (17%) HAD A NEW-ONSET ORGAN FAILURE IN THE STENT GROUP WHILE THERE ARE 7 PATIENTS (14%) ON THE PLASTIC STENT GROUP. BLEEDING OCCURRED IN 9 PATIENTS (17%) IN THE STENT GROUP WHILE THERE ARE 11 PATIENTS (22%) IN THE PLASTIC STENT GROUP. OF THE 9 PATIENTS WITH BLEEDING IN THE STENT GROUP, 4 PATIENTS (8%) REQUIRED BLOOD TRANSFUSION WHILE NONE OF THE PATIENTS IN THE PLASTIC STENT REQUIRED BLOOD TRANSFUSION; THE REMAINING 5 PATIENTS (9%) IN THE STENT GROUP REQUIRED AN ENDOSCOPIC, RADIOLOGICAL OR SURGICAL INTERVENTION TO MANAGE THE BLEEDING WHILE THERE ARE 11 PATIENTS (22%)IN THE PLASTIC STENT GROUP AFTER A MEAN OF 26 AND 37 DAYS POST DRAINAGE, RESPECTIVELY. OF THE 9 PATIENTS WITH BLEEDING IN THE STENT GROUP, 6 PATIENTS (67%) HAD INDWELLING STENTS AT THE TIME OF THE BLEEDING WHILE THERE ARE 9 OF 11 PATIENTS (82%) IN THE PLASTIC STENT GROUP. PSEUDOANEURYSMS WERE PRESENT IN 5 OF 9 PATIENTS WITH BLEEDING (56%) IN THE STENT GROUP WHILE THERE ARE 10 OF 11 PATIENTS WITH BLEEDING (91%) IN THE PLASTIC STENT GROUP. FURTHERMORE, STENT MIGRATION OCCURRED IN TWO PATIENTS (4%) IN THE STENT GROUP AND TREATED CONSERVATIVELY. THE AXIOS STENT WAS FOUND BURIED UNDER OVERGROWING MUCOSA IN TWO PATIENTS (4%) IN THE STENT GROUP, THE STENTS WERE REMOVED SUCCESSFULLY. 17 PATIENTS (32%) NEEDED PERCUTANEOUS CATHETER DRAINAGE IN THE STENT GROUP WHILE THERE ARE 14 PATIENTS (27%) IN THE PLASTIC STENT GROUP. LASTLY, THE LENGTH OF INTENSIVE CARE STAY AND HOSPITAL STAY DID NOT DIFFER BETWEEN THE TWO GROUPS. THE MEAN NUMBER OF ENDOSCOPIC, RADIOLOGICAL OR SURGICAL INTERVENTIONS FOR INFECTED NECROSIS WAS 4.9 IN THE STENT GROUP AND 4.3 IN THE PLASTIC STENT GROUP. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517393 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention