BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 21194247 · Received January 20, 2025

    Report

    Report Number
    3005099803-2024-06957
    Event Type
    Injury
    Date Received
    January 20, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

    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 IN THE PYLORUS TO TREAT A STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. THE PHYSICIAN DID NOT USE CAUTERY TO CROSS THE LESION. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT DID NOT DEPLOY DESPITE COMPLETING THE DEPLOYMENT STEP. THE PHYSICIAN THEN UNLOCKED THE CATHETER LOCK AND ADJUSTED ITS POSITION BY MOVING IT UP AND DOWN UNTIL THE DISTAL END GRADUALLY DEPLOYED, BUT THE FIRST FLANGE OF THE STENT REMAINED UNEXPANDED. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE CATHETER TO DEPLOY THE SECOND FLANGE ON THE PROXIMAL SIDE OF THE STRICTURE; HOWEVER, THE STENT UNEXPECTEDLY ADVANCED FORWARD AND FULLY DEPLOYED. THE STENT WAS REMOVED USING RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. 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 TO TREAT A STENOSIS. 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 STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556555 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0034287101 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention