BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 20777319 · Received November 26, 2024

    Report

    Report Number
    3005099803-2024-05980
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951179
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILED DEPLOYMENT FOR EDGE PROCEDURE. BLOCK D2B: PRODUCT CODE: KNS,PCU ; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K) #: K163272, K181905, K220112, K233318 ; REPORTED HERE AS THE PREMARKET / 510(K) # EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND ANOTHER AXIOS STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS GREATER THAN OR EQUAL TO 6 CM IN SIZE AND WALLED-OFF NECROSIS GREATER THAN OR EQUAL TO 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED TRANSGASTRIC TO THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707232 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0034251358 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention