BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19884829 · Received August 1, 2024

    Report

    Report Number
    3005099803-2024-03616
    Event Type
    Death
    Date Received
    August 1, 2024
    Date of Event
    July 5, 2024
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K220112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: BLOCK B5 AND G4 (PREMARKET / 510(K) #CHECK SPELLING) WERE CORRECTED. BLOCK H6: IMDRF PATIENT CODE E0511 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF MAJOR HEMORRHAGE. IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF HYPOVOLEMIC SHOCK. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF FLUOROSCOPIC IMAGES WERE TAKEN. IMDRF IMPACT CODE F2302 CAPTURES THE REPORTABLE EVENT OF BLOOD TRANSFUSION WAS ADMINISTERED. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF CARDIOPULMONARY RESUSCITATION WAS PERFORMED. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU). IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF EMBOLISATION WAS CONDUCTED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF THE PATIENT PASSED AWAY. INVESTIGATION RESULT: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENTS WERE NOT CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENTS OF RESUSCITATION, INTENSIVE CARE, IMAGING REQUIRED AND UNEXPECTED MEDICAL INTERVENTION CANNOT BE CONFIRMED BECAUSE THESE EVENTS HAPPENED DURING THE PROCEDURE AND THERE IS NOT AN OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS TO ESTABLISH THE CAUSE OF THE REPORTED EVENTS. ADDITIONALLY, CARDIAC ARREST, SHOCK, HYPOVOLEMIC, HEMORRHAGE, MAJOR, PERFORATION, VESSEL, BLOOD TRANSFUSION AND DEATH ARE KNOWN AND DOCUMENTED IN THE LABELING; THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS KNOWN INHERENT RISK OF DEVICE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINED IMPLANTED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL. ADDITIONALLY, CARDIAC ARREST, SHOCK, HYPOVOLEMIC, HEMORRHAGE, MAJOR, PERFORATION, VESSEL, BLOOD TRANSFUSION AND DEATH ARE NOTED WITHIN THE IFU AS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. RISK REVIEW A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "CARDIAC ARREST, SHOCK, HYPOVOLEMIC, HEMORRHAGE, MAJOR, PERFORATION, VESSEL, RESUSCITATION, INTENSIVE CARE, IMAGING REQUIRED, BLOOD TRANSFUSION, DEATH AND UNEXPECTED MEDICAL INTERVENTION" WERE DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF PATIENT CODE E0511 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF MAJOR HEMORRHAGE. IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF HYPOVOLEMIC SHOCK. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF FLUOROSCOPIC IMAGES WERE TAKEN. IMDRF IMPACT CODE F2302 CAPTURES THE REPORTABLE EVENT OF BLOOD TRANSFUSION WAS ADMINISTERED. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF CARDIOPULMONARY RESUSCITATION WAS PERFORMED. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF EMBOLISATION WAS CONDUCTED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF THE PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2024-03613 AND 3005099803-2024-03616 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS WERE USED TRANSDUODENAL TO THE COMMON BILE DUCT TO TREAT METASTATIC PANCREATIC AND RENAL CANCER WITH AORTIC INVOLVEMENT DURING ENDOSCOPIC ULTRASOUND (EUS)-GUIDED BILIARY DRAINAGE (EUS-BD) AND ENDOSCOPIC ULTRASOUND (EUS)-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) PROCEDURES PERFORMED ON (B)(6) 2024. DURING THE (EUS-BD) PROCEDURE, THE FIRST 8MM AXIOS STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2024-03613) WAS ADVANCED THROUGH THE SCOPE. CANNULATION INTO THE COMMON BILE DUCT WAS SUCCESSFUL; HOWEVER, THE DELIVERY SYSTEM WAS NOT ABLE TO ADVANCE RETROGRADE OVER THE GUIDEWIRE (OTW). THE FIRST AXIOS STENT WAS THEN REMOVED, BUT THE STAINLESS-STEEL PLUG INSERT WAS DETACHED FROM THE HANDLE, LEAVING A STRAND OF EXPOSED COPPER WIRE PROTRUDING FROM THE PLUG ORIFICE. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO PERFORM THE (EUS-GBD) PROCEDURE. DURING THE (EUS-GBD) PROCEDURE, THE SECOND 10MM AXIOS STENT (SUBJECT OF THIS REPORT) WAS SUCCESSFULLY IMPLANTED. HOWEVER, POST STENT PLACEMENT, THE PATIENT EXHIBITED LOW CARDIAC OUTPUT AND HAD CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS THEN PERFORMED FOR TEN MINUTES BEFORE A FEMORAL PULSE WAS DETECTED. THE PATIENT WAS TRANSFERRED TO ANGIOGRAPHY FOR IMAGING TO DETERMINE THE SOURCE OF THE BLOOD LOSS. A BLOOD TRANSFUSION WAS ADMINISTERED BEFORE AND DURING IMAGING WITH A PERFORATED ARTERIOLE OBSERVED UNDERNEATH THE DUODENAL FLANGE ON THE IMPLANTED 10MM AXIOS STENT. EMBOLIZATION WAS CONDUCTED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS TRANSFERRED TO ICU IN A STABLE CONDITION. IN THE ANESTHETIST ASSESSMENT, THE PATIENT WAS GOING INTO ANAPHYLAXIS, AND SOME ADRENALINE WAS ADMINISTERED. IN THE PHYSICIAN'S ASSESSMENT, THE PROCEDURE IS UNLIKELY TO HAVE BEEN THE PRIMARY CAUSE OF BLEEDING AS THE PATIENT'S TUMORS WERE EXTREMELY ADVANCED AND VASCULAR INVOLVEMENT WAS SIGNIFICANT ENOUGH THAT A HUGE BLEEDING WAS LIKELY WITHIN A FEW DAYS. THE PATIENT HAD LOW CARDIAC OUTPUT AND SUFFERED A CARDIAC ARREST. THE PATIENT WAS RESUSCITATED AND WAS TRANSFERRED TO THE ICU; HOWEVER, THE PATIENT HAD ANOTHER LOW CARDIAC OUTPUT AND WAS NOT ABLE TO BE RESUSCITATED, LEADING TO THE PATIENT'S DEATH ON THE EVENING OF (B)(6) 2024.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2024-03613 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS WERE USED TRANSDUODENAL TO THE COMMON BILE DUCT TO TREAT METASTATIC PANCREATIC AND RENAL CANCER WITH AORTIC INVOLVEMENT DURING ENDOSCOPIC ULTRASOUND (EUS)-GUIDED BILIARY DRAINAGE (EUS-BD) AND ENDOSCOPIC ULTRASOUND (EUS)-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) PROCEDURES PERFORMED ON (B)(6) 2024. DURING THE (EUS-BD) PROCEDURE, THE FIRST 8MM AXIOS STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2024-03613) WAS ADVANCED THROUGH THE SCOPE. CANNULATION INTO THE COMMON BILE DUCT WAS SUCCESSFUL; HOWEVER, THE DELIVERY SYSTEM WAS NOT ABLE TO ADVANCE RETROGRADE OVER THE GUIDEWIRE (OTW). THE FIRST AXIOS STENT WAS THEN REMOVED, BUT THE STAINLESS-STEEL PLUG INSERT WAS DETACHED FROM THE HANDLE, LEAVING A STRAND OF EXPOSED COPPER WIRE PROTRUDING FROM THE PLUG ORIFICE. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO PERFORM THE (EUS-GBD) PROCEDURE. DURING THE (EUS-GBD) PROCEDURE, THE SECOND 10MM AXIOS STENT (SUBJECT OF THIS REPORT) WAS SUCCESSFULLY IMPLANTED. HOWEVER, POST STENT PLACEMENT, THE PATIENT EXHIBITED LOW CARDIAC OUTPUT AND HAD CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS THEN PERFORMED FOR TEN MINUTES BEFORE A FEMORAL PULSE WAS DETECTED. THE PATIENT WAS TRANSFERRED TO ANGIOGRAPHY FOR IMAGING TO DETERMINE THE SOURCE OF THE BLOOD LOSS. A BLOOD TRANSFUSION WAS ADMINISTERED BEFORE AND DURING IMAGING WITH A PERFORATED ARTERIOLE OBSERVED UNDERNEATH THE DUODENAL FLANGE ON THE IMPLANTED 10MM AXIOS STENT. EMBOLIZATION WAS CONDUCTED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS TRANSFERRED TO ICU IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311532 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553540 0033293227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death