AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2026-00245
- Event Type
- Injury
- Date Received
- January 20, 2026
- Date of Event
- January 1, 2017
- Report Date
- March 3, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- PMA / PMN Number
- K220112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE STUDY WAS CONDUCTED, BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT UPN AND 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 G2: LITERATURE SOURCE: MANUEL PEREZ-MIRANDA, ET. AL., ": LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION" DIGESTIVE ENDOSCOPY, 2025; 37:1198-1206. HTTPS://DOI.ORG/10.1111/DEN.15087. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERFORATION. IMDRF IMPACT CODE F19 CAPTURES THE SURGICAL PROCEDURE. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE STUDY WAS CONDUCTED, BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT UPN AND 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 G2: LITERATURE SOURCE: MANUEL PEREZ-MIRANDA, ET. AL., ": LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION" DIGESTIVE ENDOSCOPY, 2025; 37:1198-1206. HTTPS://DOI.ORG/10.1111/DEN.15087. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERFORATION. IMDRF IMPACT CODE F19 CAPTURES THE SURGICAL PROCEDURE. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE. BLOCK H11: THE DEVICE WAS NOT RETURNED; THEREFORE, TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE /PRODUCT LABEL. THE IFU STATES: "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE" AND "CAUTION: THE AXIOS IS INTENDED FOR IMPLANTATION UP TO 60 DAYS"; HOWEVER, IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. ADDITIONALLY, STENT OBSTRUCTION WITHIN DEVICE, SURGICAL INTERVENTION AND PERFORATION WERE NOTED WITHIN THE DFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS KNOWN INHERENT RISK OF DEVICE.
BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH AN ARTICLE TITLED, "LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION", BY MANUEL PEREZ- MIRANDA, ET AL. THE STUDY AIMED TO EVALUATE LONG-TERM CLINICAL OUTCOMES OF EUS-GE IN BENIGN GASTRIC OUTLET OBSTRUCTION (BGOO). ACCORDING TO THE ARTICLE, A MULTICENTER RETROSPECTIVE STUDY WAS CONDUCTED ACROSS NINE CENTERS INVOLVING PATIENTS WHO UNDERWENT EUS-GE FOR THE TREATMENT OF BGOO. PATIENTS SCHEDULED FOR EUS-GE WITH LAMS BETWEEN JANUARY 2017 AND JUNE 2023 WERE CONSIDERED ELIGIBLE. THERE WERE 62 PATIENTS INCLUDED FOR ANALYSIS. MOST CASED OF BGOO WERE RELATED TO PANCREATIC DISEASE. ACCORDING TO THE ARTICLE, THE STUDY PATIENTS EXPERIENCED SEVERAL COMPLICATIONS, INCLUDING PERFORATION, COMPLETE LAMS EMBEDMENT (RESULTING IN STENT OBSTRUCTION), AND ORAL INTOLERANCE THAT REQUIRED BOTH SURGICAL INTERVENTION AND A SECOND EUS-GE PROCEDURE. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. HOWEVER, THE AXIOS STENT ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE THAT "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE." FURTHERMORE, THE INSTRUCTIONS FOR USE STATE "CAUTION: THE AXIOS IS INTENDED FOR IMPLANTATION UP TO 60 DAYS." THE STENT IS NOT INTENDED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION OR TO REMAIN IMPLANTED FOR MORE THAN 60 DAYS.
BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH AN ARTICLE TITLED, "LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION", BY MANUEL PEREZ- MIRANDA, ET AL. THE STUDY AIMED TO EVALUATE LONG-TERM CLINICAL OUTCOMES OF EUS-GE IN BENIGN GASTRIC OUTLET OBSTRUCTION (BGOO). ACCORDING TO THE ARTICLE, A MULTICENTER RETROSPECTIVE STUDY WAS CONDUCTED ACROSS NINE CENTERS INVOLVING PATIENTS WHO UNDERWENT EUS-GE FOR THE TREATMENT OF BGOO. PATIENTS SCHEDULED FOR EUS-GE WITH LAMS BETWEEN JANUARY 2017 AND JUNE 2023 WERE CONSIDERED ELIGIBLE. THERE WERE 62 PATIENTS INCLUDED FOR ANALYSIS. MOST CASED OF BGOO WERE RELATED TO PANCREATIC DISEASE. ACCORDING TO THE ARTICLE, THE STUDY PATIENTS EXPERIENCED SEVERAL COMPLICATIONS, INCLUDING PERFORATION, COMPLETE LAMS EMBEDMENT (RESULTING IN STENT OBSTRUCTION), AND ORAL INTOLERANCE THAT REQUIRED BOTH SURGICAL INTERVENTION AND A SECOND EUS-GE PROCEDURE. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. HOWEVER, THE AXIOS STENT ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE THAT "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE." FURTHERMORE, THE INSTRUCTIONS FOR USE STATE "CAUTION: THE AXIOS IS INTENDED FOR IMPLANTATION UP TO 60 DAYS." THE STENT IS NOT INTENDED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION OR TO REMAIN IMPLANTED FOR MORE THAN 60 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177977 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |