BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 20789151 · Received November 26, 2024

    Report

    Report Number
    3005099803-2024-06052
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    October 31, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: KNS, PCU REPORTED HERE AS THE FIRST NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4 : PREMARKET / 510(K) # : K163272, K181905, K220112, K233318 REPORTED HERE AS THE FIRST NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILED TO DEPLOY FOR GASTROJEJUNOSTOMY PROCEDURE. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF HANDLE BREAK FOR GASTROJEJUNOSTOMY PROCEDURE. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGERY PERFORMED.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2024-06051 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE JEJUNUM TO TREAT A DUODENAL OBSTRUCTION DURING A GASTROJEJUNOSTOMY PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE AXIOS STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE HANDLE BROKE AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PHYSICIAN PASSED A GUIDEWIRE THROUGH THE AXIOS STENT AND PROCEEDED TO REMOVE THE STENT, WITH THE STENT FULLY COVERED BY THE OUTER SHEATH. A 15MM AXIOS STENT WAS THEN USED (THE SUBJECT OF MFR. REPORT # 3005099803-2024-06051); HOWEVER, THE AXIOS CAUTERY DID NOT WORK, AND PARTIAL BLANCHING OF THE TISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A FEVER, AND THE PHYSICIAN WAS CONCERNED ABOUT POTENTIAL COMPLICATIONS DUE TO A PUNCTURE SITE THAT WAS NOT ADDRESSED BY THE STENT; HENCE A LAPAROSCOPIC PROCEDURE WAS PERFORMED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR A GASTROJEJUNOSTOMY 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 PLACEMENT TRANSGASTRIC TO THE JEJUNUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360276 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0034468202 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention