AXIOS
Report
- Report Number
- 3005099803-2024-05982
- Event Type
- Malfunction
- Date Received
- November 25, 2024
- Date of Event
- October 30, 2024
- Report Date
- December 24, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K163272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRODUCT CODE: KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K) #: K163272, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET # EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND.
BLOCK D2B: PRODUCT CODE: KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K) #: K163272, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET # EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. BLOCK H11: AN AXIOS ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS; THE STENT WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE DID NOT FIND ANY DAMAGES TO THE DELIVERY SYSTEM. THE REPORTED EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND CANNOT BE CONFIRMED AS THE STENT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE AVAILABLE INFORMATION, THERE IS NOT ENOUGH INFORMATION TO CONFIRM THE REPORTED EVENT; THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A WALLED-OFF-NECROSIS (WON) DURING A PANCREATIC CYST GASTRIC BYPASS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED; HOWEVER, THE FLANGE DID NOT OPEN. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A WALLED-OFF-NECROSIS (WON) DURING A PANCREATIC CYST GASTRIC BYPASS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED; HOWEVER, THE FLANGE DID NOT OPEN. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1707643 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0033431746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |