AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2025-03410
- Event Type
- Injury
- Date Received
- July 30, 2025
- Date of Event
- October 1, 2016
- Report Date
- November 18, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H2 (CORRECTION): BLOCK H6 (PATIENT AND IMPACT CODES) HAVE BEEN CORRECTED. PER MEDICAL REVIEW, THE PATIENTS' DEVELOPMENT OF DIABETES WAS FROM THE DISEASE PROGRESSION. THERE IS NO ALLEGATION AGAINST THE DEVICE OR RELATED ADVERSE EVENTS. THUS, THIS EVENT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE EVENT WERE TO OCCUR. BASED UPON THE ADDITIONAL INFORMATION RECEIVED BOSTON SCIENTIFIC NO LONGER CONSIDERS THIS TO BE REPORTABLE EVENT. BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF OCTOBER 1, 2016, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN OCTOBER 2016 AND JANUARY 2022. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE 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 E1: INITIAL REPORTER FACILITY NAME: (B)(6); REPORTED HERE AS THE FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: TEODORA MAN; ALICE SPULBER SFARA; LIDIA NEAMTI; ALEXANDRU ISTRATE; MONICA MIHAELA MARTA; CRISTINA POJOGA; RADU SEICEAN; VOICU REDNIC; ANDRADA SEICEAN. "NEW-ONSET DIABETES MELLITUS AFTER EUS-GUIDED DRAINAGE WITH LAMS: A PILOT STUDY", J GASTROINTESTIN LIVER DIS. 2024 MAR 29;33(1):65-73, HTTP://DX.DOI.ORG/10.15403/JGLD-5142.
BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF OCTOBER 1, 2016, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN OCTOBER 2016 AND JANUARY 2022. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE 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 E1: INITIAL REPORTER FACILITY NAME: IULIU HATIEGANU UNIVERSITY OF MEDICINE AND PHARMACY; REPORTED HERE AS THE FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: TEODORA MAN; ALICE SPULBER SFARA; LIDIA NEAMTI; ALEXANDRU ISTRATE; MONICA MIHAELA MARTA; CRISTINA POJOGA; RADU SEICEAN; VOICU REDNIC; ANDRADA SEICEAN. "NEW-ONSET DIABETES MELLITUS AFTER EUS-GUIDED DRAINAGE WITH LAMS: A PILOT STUDY", J GASTROINTESTIN LIVER DIS. 2024 MAR 29;33(1):65-73, HTTP://DX.DOI.ORG/10.15403/JGLD-5142. BLOCK H6: IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF A NEW ONSET OF DIABETES. IMDRF PATIENT CODE E2115 CAPTURES THE REPORTABLE EVENT OF POST-OPERATIVE WOUND INFECTION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE TITLED, "NEW-ONSET DIABETES MELLITUS AFTER EUS-GUIDED DRAINAGE WITH LAMS: A PILOT STUDY", BY TEODORA MAN ET AL. PER THE ARTICLE, BETWEEN OCTOBER 2016 AND JANUARY 2022, 50 PATIENTS SUFFERING FROM ACUTE/SEVERE OR NECROTIZING PANCREATITIS WITH WALLED OFF NECROSIS UNDERWENT EUS-GUIDED DRAINAGE USING AXIOS AS LUMEN-APPOSING METAL STENTS (LAMS). THE ARTICLE INDICATED THAT SOME PATIENTS SUFFERED FROM NEW ONSET OF DIABETES POSTOPERATIVELY, AND FREQUENT NECROSIS. THESE ADVERSE EVENTS WERE TREATED WITH INSULIN THERAPY, DIRECT ENDOSCOPIC NECROSECTOMY, AND AN ADDITIONAL PLASTIC STENT. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE TITLED, "NEW-ONSET DIABETES MELLITUS AFTER EUS-GUIDED DRAINAGE WITH LAMS: A PILOT STUDY", BY TEODORA MAN ET AL. PER THE ARTICLE, BETWEEN OCTOBER 2016 AND JANUARY 2022, 50 PATIENTS SUFFERING FROM ACUTE/SEVERE OR NECROTIZING PANCREATITIS WITH WALLED OFF NECROSIS UNDERWENT EUS-GUIDED DRAINAGE USING AXIOS AS LUMEN-APPOSING METAL STENTS (LAMS). THE ARTICLE INDICATED THAT SOME PATIENTS SUFFERED FROM NEW ONSET OF DIABETES POSTOPERATIVELY, AND FREQUENT NECROSIS. THESE ADVERSE EVENTS WERE TREATED WITH INSULIN THERAPY, DIRECT ENDOSCOPIC NECROSECTOMY, AND AN ADDITIONAL PLASTIC STENT. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447654 | 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 |