FDA Adverse Event
Malfunction
Summary report: N
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
MDR report key: 23983536
·
Received January 6, 2026
Report
- Report Number
- 3005099803-2026-00062
- Event Type
- Malfunction
- Date Received
- January 6, 2026
- Date of Event
- September 29, 2025
- Report Date
- January 6, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- UDI-DI
- 08714729951100
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING AN ENDOSCOPIC PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS STENT DISTAL FLANGE DID NOT DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44594 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | M00553560 | 0035691975 | 08714729951100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |