BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 11871057 · Received May 24, 2021

    Report

    Report Number
    3005099803-2021-02350
    Event Type
    Death
    Date Received
    May 24, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B1, B2, B5, H1, H6 (PATIENT AND IMPACT CODES) AND H10 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2022 AND MARCH 1, 2022. BLOCK G3: 92147168 AXIOS FOR GALLBLADDER DRAINAGE IDE CLINICAL STUDY. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A1409 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. PATIENT CODE: E233605 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF SEPTIC SHOCK. IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED; 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.

    Additional Manufacturer Narrative · 0

    BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON APRIL 20, 2022. BLOCK G3: 92147168 AXIOS FOR GALLBLADDER DRAINAGE IDE CLINICAL STUDY. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A1409 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. PATIENT CODE E233605 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF SEPTIC SHOCK. IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED; 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. BLOCK H11: BLOCKS D1 (BRAND NAME) AND E1 (INITIAL REPORTER CITY AND ZIP CODE) HAVE BEEN CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 03, 2021, THAT A HOT AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO THE GALLBLADDER ON (B)(6) 2021 AS PART OF THE 92147168 AXIOS FOR GALLBLADDER DRAINAGE IDE CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2021. DURING THE PER PROTOCOL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021, TISSUE INGROWTH WITHIN THE STENT WAS NOTED. THE STENT WAS REMOVED USING GRASPERS AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT'S INDICATION WAS RESOLVED AT THE TIME OF THE REMOVAL PROCEDURE. AN ULCERATION INVOLVING MUCOSA WAS NOTED AT THE TIME OF STENT REMOVAL. IT IS UNKNOWN IF THE ULCERATION WAS RELATED TO THE AXIOS OR IF THERE WERE ANY INTERVENTIONS. ON (B)(6) 2021, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR PAIN RIGHT HYPOCHONDER DUE TO GALLBLADDER POLYP. THERE WAS NO RELATIONSHIP BETWEEN THE PAIN AND THE HOT AXIOS STENT OR THE PLACEMENT AND REMOVAL PROCEDURES. THE PATIENT PASSED AWAY ON (B)(6) 2021 FROM CARDIAC DEATH DUE TO UNDERLYING HEART DISEASE. THERE WAS NO RELATIONSHIP BETWEEN THE CARDIAC DEATH/ DEATH OF THE PATIENT AND THE HOT AXIOS STENT OR THE PLACEMENT AND REMOVAL PROCEDURES. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2022 AND MARCH 1, 2022. IT WAS REPORTED THAT DURING STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021, TWO NON- BOSTON SCIENTIFIC STENTS WERE IMPLANTED TO KEEP OUTFLOW FROM THE GALLBLADDER. THE PATIENT WAS ADMITTED TO THE HEPATOLOGY DEPARTMENT ON (B)(6) 2021 DUE TO RECURRENCE OF COLIC PAIN IN CONNECTION WITH RECURRENT ISSUES OF CALCULOUS CHOLECYSTITIS AND STENT MIGRATION. THE PATIENT WAS SCHEDULED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE NEXT DAY AND WAS GIVEN AUGMENTIN IV. ON (B)(6) 2021, THE PATIENT SHOWED SIGNS OF SHOCK (HYPOTENSION, REDUCED AWARENESS (GLASGOW COMA SCALE 12/15) AND THE NEED FOR OXYGEN UP TO 5L. THE PATIENT WAS GIVEN AGGRESSIVE FLUID RESUSCITATION WITH AN INITIALLY POSITIVE RESPONSE. A FEW HOURS LATER, DURING ETIOLOGY WORKUP (PRESUMABLY SEPSIS IN VIEW OF CLINICAL PICTURE AND THE RISE OF C-REACTIVE PROTEIN (CRP) TO 280 MG/L), THE PATIENT EXPERIENCED CARDIAC ARREST. THORACIC MASSAGE WAS STARTED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED; HOWEVER, THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, SEPTIC SHOCK RESULTING IN THE PATIENT'S DEATH IS POSSIBLY RELATED TO THE AXIOS STENT AND STENT PLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 03, 2021 THAT A HOT AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO THE GALLBLADDER ON (B)(6) 2021 AS PART OF THE 92147168 AXIOS FOR GALLBLADDER DRAINAGE IDE CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2021. DURING THE PER PROTOCOL STENT REMOVAL PROCEDURE PERFORMED ON MARCH 23, 2021, TISSUE INGROWTH WITHIN THE STENT WAS NOTED. THE STENT WAS REMOVED USING GRASPERS AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT'S INDICATION WAS RESOLVED AT THE TIME OF THE REMOVAL PROCEDURE. AN ULCERATION INVOLVING MUCOSA WAS NOTED AT THE TIME OF STENT REMOVAL. IT IS UNKNOWN IF THE ULCERATION WAS RELATED TO THE AXIOS OR IF THERE WERE ANY INTERVENTIONS. ON (B)(6) 2021 THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR PAIN RIGHT HYPOCHONDER DUE TO GALLBLADDER POLYP. THERE WAS NO RELATIONSHIP BETWEEN THE PAIN AND THE HOT AXIOS STENT OR THE PLACEMENT AND REMOVAL PROCEDURES. THE PATIENT PASSED AWAY ON (B)(6) 2021 FROM CARDIAC DEATH DUE TO UNDERLYING HEART DISEASE. THERE WAS NO RELATIONSHIP BETWEEN THE CARDIAC DEATH/ DEATH OF THE PATIENT AND THE HOT AXIOS STENT OR THE PLACEMENT AND REMOVAL PROCEDURES. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2022 AND MARCH 1, 2022 IT WAS REPORTED THAT DURING STENT REMOVAL PROCEDURE PERFORMED ON MARCH 23, 2021, TWO NON- BOSTON SCIENTIFIC STENTS WERE IMPLANTED TO KEEP OUTFLOW FROM THE GALLBLADDER. THE PATIENT WAS ADMITTED TO THE HEPATOLOGY DEPARTMENT ON (B)(6 2021 DUE TO RECURRENCE OF COLIC PAIN IN CONNECTION WITH RECURRENT ISSUES OF CALCULOUS CHOLECYSTITIS AND STENT MIGRATION. THE PATIENT WAS SCHEDULED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE NEXT DAY AND WAS GIVEN AUGMENTIN IV. ON (B)(6) 2021, THE PATIENT SHOWED SIGNS OF SHOCK (HYPOTENSION, REDUCED AWARENESS (GLASGOW COMA SCALE 12/15) AND THE NEED FOR OXYGEN UP TO 5L. THE PATIENT WAS GIVEN AGGRESSIVE FLUID RESUSCITATION WITH AN INITIALLY POSITIVE RESPONSE. A FEW HOURS LATER, DURING ETIOLOGY WORKUP (PRESUMABLY SEPSIS IN VIEW OF CLINICAL PICTURE AND THE RISE OF C-REACTIVE PROTEIN (CRP) TO 280 MG/L), THE PATIENT EXPERIENCED CARDIAC ARREST. THORACIC MASSAGE WAS STARTED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED; HOWEVER, THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, SEPTIC SHOCK RESULTING IN THE PATIENT'S DEATH IS POSSIBLY RELATED TO THE AXIOS STENT AND STENT PLACEMENT PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON APRIL 20, 2022: IT WAS REPORTED THAT THE TISSUE INGROWTH NOTED WAS THAT THE STENT WAS PARTIALLY BURIED IN THE GASTRIC WALL. PHOTOS OF THE PLANNED AXIOS REMOVAL PROCEDURE WERE RECEIVED SHOWING THE STENT WAS PARTIALLY BURIED IN THE GASTRIC WALL AND WAS IMPACTED WITH FOOD DEBRIS. THE PHOTOS ALSO SHOW STONES IN THE GALLBLADDER AND FOOD DEBRIS WERE REMOVED WITH A SNARE AND A PLASTIC PIGTAIL STENT WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(4) AXIOS FOR GALLBLADDER DRAINAGE IDE CLINICAL STUDY. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED; 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 MAY 03, 2021 THAT A HOT AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO THE GALLBLADDER ON (B)(6) 2021 AS PART OF THE 92147168 AXIOS FOR GALLBLADDER DRAINAGE IDE CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2021. DURING THE PER PROTOCOL STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021, TISSUE INGROWTH WITHIN THE STENT WAS NOTED. THE STENT WAS REMOVED USING GRASPERS AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT'S INDICATION WAS RESOLVED AT THE TIME OF THE REMOVAL PROCEDURE. AN ULCERATION INVOLVING MUCOSA WAS NOTED AT THE TIME OF STENT REMOVAL. IT IS UNKNOWN IF THE ULCERATION WAS RELATED TO THE AXIOS OR IF THERE WERE ANY INTERVENTIONS. ON (B)(6) 2021 THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR PAIN RIGHT HYPOCHONDER DUE TO GALLBLADDER POLYP. THERE WAS NO RELATIONSHIP BETWEEN THE PAIN AND THE HOT AXIOS STENT OR THE PLACEMENT AND REMOVAL PROCEDURES. THE PATIENT PASSED AWAY ON (B)(6) 2021 FROM CARDIAC DEATH DUE TO UNDERLYING HEART DISEASE. THERE WAS NO RELATIONSHIP BETWEEN THE CARDIAC DEATH/ DEATH OF THE PATIENT AND THE HOT AXIOS STENT OR THE PLACEMENT AND REMOVAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768828 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550 0026669663

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention| H| D