AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2026-00376
- Event Type
- Death
- Date Received
- January 30, 2026
- Date of Event
- November 1, 2025
- Report Date
- March 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QXH
- UDI-DI
- 08714729904557
- PMA / PMN Number
- K150692
- Removal / Correction Number
- 3005099803-12192025-004-
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: THE EVENT DATE IS UNKNOWN AND WAS APPROXIMATED BASED ON THE PATIENT'S DATE OF DEATH. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE (BLEEDING). IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E1108 CAPTURES THE REPORTABLE EVENT OF BILIARY LEAK. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. BLOCK H11: BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON 19-DEC-2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. DESPITE MULTIPLE EFFORTS, BSC WAS UNABLE TO CONFIRM THE BATCH NUMBER FOR THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM USED IN THIS EVENT. BASED ON THE REPORTED CLINICAL OBSERVATIONS ASSOCIATED WITH STENT FAILURE TO DEPLOY AND THE DATE BSC WAS INFORMED OF THIS EVENT, BSC IS CONSERVATIVELY ASSOCIATING THIS EVENT WITH THE RECALL IN AN ABUNDANCE OF CAUTION. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.
BLOCK B3: THE EVENT DATE IS UNKNOWN AND WAS APPROXIMATED BASED ON THE PATIENT'S DATE OF DEATH. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE (BLEEDING). IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E1108 CAPTURES THE REPORTABLE EVENT OF BILIARY LEAK. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. BLOCK H11: INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENTS OF STENT POSITIONING ISSUE, STENT PARTIALLY DEPLOYED, AND DELIVERY SYSTEM DIFFICULT TO ADVANCE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, STENT POSITIONING ISSUE, STENT PARTIALLY DEPLOYED, HEMORRHAGE, MAJOR, PERFORATION, BILIARY LEAK, SURGICAL INTERVENTION AND DEATH ARE NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. ADDITIONALLY, THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE DELIVERY SYSTEM DIFFICULT TO ADVANCE WAS DUE TO THE PHYSICIAN'S MANIPULATION OR TECHNIQUE DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; 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, STENT POSITIONING ISSUE, STENT PARTIALLY DEPLOYED, HEMORRHAGE, MAJOR, PERFORATION, BILIARY LEAK, SURGICAL INTERVENTION AND DEATH ARE NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. RISK REVIEW A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT POSITIONING ISSUE, STENT PARTIALLY DEPLOYED, DELIVERY SYSTEM DIFFICULT TO ADVANCE, HEMORRHAGE, MAJOR, PERFORATION, BILIARY LEAK, ADDITIONAL DEVICE REQUIRED, SURGICAL INTERVENTION AND DEATH" WERE DEFINED IN THE RISK DOCUMENTATION AND ARE 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. BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON 19-DEC-2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. DESPITE MULTIPLE EFFORTS, BSC WAS UNABLE TO CONFIRM THE BATCH NUMBER FOR THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM USED IN THIS EVENT. BASED ON THE REPORTED CLINICAL OBSERVATIONS ASSOCIATED WITH STENT FAILURE TO DEPLOY AND THE DATE BSC WAS INFORMED OF THIS EVENT, BSC IS CONSERVATIVELY ASSOCIATING THIS EVENT WITH THE RECALL IN AN ABUNDANCE OF CAUTION. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT (CBD) TO FACILITATE A BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE FIRST STENT, BUT IT DID NOT DEPLOY. THEREFORE, A GUIDEWIRE DEEP INTO THE SEGMENTAL DUCTS WAS PLACED. AFTER THAT, WHEN INSERTING THE STENT IN THE WORKING CHANNEL, THE GUIDEWIRE DISLODGED, THEN THE PHYSICIAN HAD TO REPLACE THE WIRE BY NEEDLING THE CBD WITH A BOSTON SCIENTIFIC 19-G FNA NEEDLE. AFTER PLACEMENT OF THE WIRE, A SECOND STENT OF THE SAME SIZE WAS INSERTED. THE LAMS COULD NOT BE ADVANCED FAR ENOUGH DUE TO COLLAPSED BILE DUCTS AND TOO MUCH BILE IN-BETWEEN CBD AND DUODENUM. THE PHYSICIAN DEPLOYED THE DISTAL FLANGE GRADUALLY IN ORDER TO ADVANCE THE INNER SYSTEM DEEPER INTO THE DUCT. NEVERTHELESS, THE SECOND LAMS DEPLOYED IN-BETWEEN DUODENUM AND DUCT AND HAD TO BE REMOVED AFTER PARTIAL DEPLOYMENT. AFTER THAT THE PATIENT WENT FOR SURGERY. THE PATIENT UNDERWENT SURGICAL CLOSURE OF A DUODENAL PERFORATION (FOLLOWING LAMS INSERTION), PLACEMENT OF AN EXTERNAL DRAINAGE TUBE FOR BILE LEAKAGE FROM THE COMMON BILE DUCT, AND A SURGICAL GASTROENTEROSTOMY AND SUBSEQUENTLY REQUIRED PTBD (PERCUTANEOUS TRANSHEPATIC BILIARY AND DRAINAGE). UNFORTUNATELY, THE PTBD PROCEDURE WAS COMPLICATED BY ACTIVE VENOUS SUBCAPSULAR BLEEDING AT THE INSERTION SITE. PTBD AFTER TWO DAYS WAS NECESSARY TO DRAIN THE BILE DUCTS TO THE OUTSIDE, AND IT WAS REPORTED THAT THE PATIENT ULTIMATELY PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT'S DEATH RESULTED FROM HYPOVOLEMIC SHOCK DUE TO SUBCAPSULAR LIVER BLEEDING AFTER PTBD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT (CBD) TO FACILITATE A BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE FIRST STENT, BUT IT DID NOT DEPLOY. THEREFORE, A GUIDEWIRE DEEP INTO THE SEGMENTAL DUCTS WAS PLACED. AFTER THAT, WHEN INSERTING THE STENT IN THE WORKING CHANNEL, THE GUIDEWIRE DISLODGED, THEN THE PHYSICIAN HAD TO REPLACE THE WIRE BY NEEDLING THE CBD WITH A BOSTON SCIENTIFIC 19-G FNA NEEDLE. AFTER PLACEMENT OF THE WIRE, A SECOND STENT OF THE SAME SIZE WAS INSERTED. THE LAMS COULD NOT BE ADVANCED FAR ENOUGH DUE TO COLLAPSED BILE DUCTS AND TOO MUCH BILE IN-BETWEEN CBD AND DUODENUM. THE PHYSICIAN DEPLOYED THE DISTAL FLANGE GRADUALLY IN ORDER TO ADVANCE THE INNER SYSTEM DEEPER INTO THE DUCT. NEVERTHELESS, THE SECOND LAMS DEPLOYED IN-BETWEEN DUODENUM AND DUCT AND HAD TO BE REMOVED AFTER PARTIAL DEPLOYMENT. AFTER THAT THE PATIENT WENT FOR SURGERY. THE PATIENT UNDERWENT SURGICAL CLOSURE OF A DUODENAL PERFORATION (FOLLOWING LAMS INSERTION), PLACEMENT OF AN EXTERNAL DRAINAGE TUBE FOR BILE LEAKAGE FROM THE COMMON BILE DUCT, AND A SURGICAL GASTROENTEROSTOMY AND SUBSEQUENTLY REQUIRED PTBD (PERCUTANEOUS TRANSHEPATIC BILIARY AND DRAINAGE). UNFORTUNATELY, THE PTBD PROCEDURE WAS COMPLICATED BY ACTIVE VENOUS SUBCAPSULAR BLEEDING AT THE INSERTION SITE. PTBD AFTER TWO DAYS WAS NECESSARY TO DRAIN THE BILE DUCTS TO THE OUTSIDE, AND IT WAS REPORTED THAT THE PATIENT ULTIMATELY PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT'S DEATH RESULTED FROM HYPOVOLEMIC SHOCK DUE TO SUBCAPSULAR LIVER BLEEDING AFTER PTBD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284341 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM | QXH | BOSTON SCIENTIFIC CORPORATION | M00553530 | 08714729904557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| R |