BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 11814138 · Received May 12, 2021

    Report

    Report Number
    3005099803-2021-02154
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729951179
    PMA / PMN Number
    K163272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PHYSICIAN DID NOT USED CAUTERY TO CROSS THE LESION. DURING THE PROCEDURE, THE SECOND FLANGE DID NOT RELEASE FROM THE CATHETER. THE PHYSICIAN ATTEMPTED TO MOVE THE CATHETER BACK AND FORTH BUT THE SECOND FLANGE STILL DID NOT RELEASE. AS THE PHYSICIAN ATTEMPTED TO PULL THE FIRST FLANGE BACK THROUGH THE STRICTURE AND THROUGH THE SCOPE, THE STENT FULLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT USING RESCUE RAT TOOTH COMBO FORCEPS AND THE PROCEDURE WAS COMPLETED USING A DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED IN THE DUODENUM TO TREAT A MALIGNANT STRICTURE. 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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE HOT AXIOS STENT IS NOT INDICATED TO BE IMPLANTED TO TREAT DUODENAL STRICTURES . IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. THE HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE STATE "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711761 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553660 0026864742 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention