BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS

    MDR report key: 11745134 · Received April 29, 2021

    Report

    Report Number
    3005099803-2021-01915
    Event Type
    Death
    Date Received
    April 29, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729951179
    PMA / PMN Number
    K163272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2021 AS THE EVENT OCCURRED BEFORE (B)(6) 2021 WHEN THE ARTICLE WAS PUBLISHED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. LITERATURE SOURCE: PATEL, R. H., EVERETT, B. T., AKSELROD, D., FRASCA, J. D., & GORDON, S. R. (2021). FATAL AORTOESOPHAGEAL FISTULA COMPLICATING PLACEMENT OF A 20-MM LUMEN-APPOSING METAL STENT FOR REFRACTORY ESOPHAGOJEJUNAL ANASTOMOTIC STRICTURE. ACG CASE REPORTS JOURNAL, 8(3). DOI:10.14309/CRJ.0000000000000548. (B)(4). THE PATIENT EXPIRED, THE STENT REMAINS IMPLANTED 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

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A HOT AXIOS STENT THROUGH THE ARTICLE "FATAL AORTOESOPHAGEAL FISTULA COMPLICATING PLACEMENT OF A 20-MM LUMEN-APPOSING METAL STENT FOR REFRACTORY ESOPHAGOJEJUNAL ANASTOMOTIC STRICTURE" BY DR. RUPAL H. PATEL, ET AL. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 05, 2021 THAT A HOT AXIOS STENT WAS IMPLANTED TO TREAT A BENIGN REFRACTORY ESOPHAGOJEJUNAL ANASTOMOTIC STRICTURE IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PLAN WAS TO LEAVE THE AXIOS IMPLANTED FOR 12 WEEKS. DURING THE PROCEDURE, THE AXIOS STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, 6 WEEKS AFTER THE STENT PLACEMENT PROCEDURE THE PATIENT EXPERIENCED HEMATEMESIS AND HEMODYNAMIC INSTABILITY. AN UPPER ENDOSCOPY WAS PERFORMED AND RAPID ARTERIAL HEMORRHAGE FROM THE DISTAL EDGE OF THE STENT WAS NOTED. COMPUTERIZED TOMOGRAPHY ANGIOGRAM AND ARTERIOGRAM WERE ALSO PERFORMED AND AN AORTOENTERIC FISTULA WAS NOTED, AS WELL AS, EROSION OF THE DISTAL FLANGE INTO THE AORTA. THE AORTOENTERIC FISTULA WAS TREATED WITH AN ENDOVASCULAR STENT GRAFT; HOWEVER, THE PATIENT SUBSEQUENTLY DEVELOPED SEPTIC SHOCK FROM ESCHERICHIA COLI BACTEREMIA AND PASSED AWAY THE NEXT DAY. IN THE PHYSICIAN'S ASSESSMENT, THERE WAS A RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE AXIOS STENT. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE PHYSICIAN REPORTED IT MIGHT BE BEST TO AVOID USING THE 20-MM LAMS FOR BENIGN REFRACTORY ESOPHAGEAL STRICTURES AND INSTEAD USE THE SMALLER 15-MM LAMS. THE PHYSICIAN SUSPECTS THAT THE SIZE OF AXIOS AND THE RADIAL FORCE EXERTED BY THE FLANGE WIDTH MAY HAVE RESULTED IN THE DEVELOPMENT OF THE AORTOESOPHAGEAL FISTULA. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A BENIGN REFRACTORY ESOPHAGOJEJUNAL ANASTOMOTIC STRICTURE IN THE ESOPHAGUS. HOWEVER, PER THE HOT 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 IN THE ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643244 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553660 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| O