BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 20972689 · Received December 18, 2024

    Report

    Report Number
    3005099803-2024-06479
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 23, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. PREMARKET / 510(K)#: DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED.

    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 TRANSDUODENAL TO THE GALLBLADDER TO TREAT AN ACUTE CHOLECYSTITIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED. THE SECOND FLANGE OF THE STENT WAS THEN ATTEMPTED TO BE DEPLOYED; HOWEVER, THE GRAY DEPLOYMENT HUB BROKE IN HALF. THE PHYSICIAN ATTEMPTED TO RE-ATTACH THE DEPLOYMENT HUB TO DEPLOY THE SECOND FLANGE BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND THE PUNCTURE SITE WAS CLOSED WITH AN OVESCO CLIP. THE PHYSICIAN IMPLANTED ANOTHER AXIOS STENT TRANSGASTRICALLY INTO THE GALLBLADDER AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098864 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553640 0031179442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention