BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS

    MDR report key: 21039745 · Received December 30, 2024

    Report

    Report Number
    3005099803-2024-06705
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K163272, K181905, K220112, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF STENT COVER DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE STOMACH FOR DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE AXIOS STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, IT WAS NOTED THAT A PORTION OF THE STENT WAS NOT COVERED BY THE STENT COVER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT, AND THE PHYSICIAN PLANS TO REMOVE IT IN ABOUT TEN WEEKS TO PREVENT TISSUE INGROWTH. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR AN EDGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211777 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0033765262 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown