AXIOS
Report
- Report Number
- 3005099803-2024-06904
- Event Type
- Injury
- Date Received
- January 17, 2025
- Date of Event
- December 18, 2024
- Report Date
- June 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K233318
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K163272, K181905, K220112, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF SHEATH MATERIAL SEPARATION IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM DIFFICULT TO REMOVE BLOCK H11: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE NOT RETURNED FOR ANALYSIS. HOWEVER, SAMPLE PHOTOS WERE PROVIDED WHERE IT CAN BE OBSERVED THE DEVICE WITH EVIDENCE OF THE BLACK MARKER DETACHED (SHEATH MATERIAL SEPARATION) AND THE STENT NOT FULLY EXPANDED. WITH THE SAMPLE PHOTOS PROVIDED, THE PRODUCT ANALYSIS CONFIRMED ALL THE REPORTED EVENTS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE IFU (INSTRUCTIONS FOR USE) / PRODUCT LABEL. THE COMPLAINANT REPORTED THAT THE DEVICE WAS INTENDED TO BE PLACED FOR AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE. THE IFU STATES, "THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR PLACEMENT FOR AN EDGE PROCEDURE. IN OCTOBER 2024, BOSTON SCIENTIFIC INITIATED A NON-CONFORMING EVENTS PREVENTION (NCEP) INVESTIGATION TO FURTHER ANALYZE COMPLAINTS RELATED TO THE SEPARATION OF THE OUTER SHEATH DISTAL BLACK TIP. A CORRECTIVE AND PREVENTIVE ACTION INVESTIGATION (CAPA-00008322) HAS BEEN OPENED TO FURTHER INVESTIGATE THESE EVENTS AND DETERMINE IF ADDITIONAL CORRECTIVE ACTIONS ARE WARRANTED TO FURTHER ENHANCE/OPTIMIZE PRODUCT PERFORMANCE. THIS INVESTIGATION IS CURRENTLY IN PROCESS.
BLOCK G4 (PREMARKET/510(K) AND H11 HAVE BEEN CORRECTED. BLOCK H6: IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF SHEATH MATERIAL SEPARATION IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM DIFFICULT TO REMOVE BLOCK H11: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE NOT RETURNED FOR ANALYSIS. HOWEVER, SAMPLE PHOTOS WERE PROVIDED WHERE IT CAN BE OBSERVED THE DEVICE WITH EVIDENCE OF THE BLACK MARKER DETACHED (SHEATH MATERIAL SEPARATION) AND THE STENT NOT FULLY EXPANDED. WITH THE SAMPLE PHOTOS PROVIDED, THE PRODUCT ANALYSIS CONFIRMED ALL THE REPORTED EVENTS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE IFU (INSTRUCTIONS FOR USE) / PRODUCT LABEL. THE COMPLAINANT REPORTED THAT THE DEVICE WAS INTENDED TO BE PLACED FOR AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE. THE IFU STATES, "THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR PLACEMENT FOR AN EDGE PROCEDURE. IN (B)(6) 2024, BOSTON SCIENTIFIC INITIATED A NON-CONFORMING EVENTS PREVENTION (NCEP) INVESTIGATION TO FURTHER ANALYZE COMPLAINTS RELATED TO THE SEPARATION OF THE OUTER SHEATH DISTAL BLACK TIP. THE INVESTIGATION FOUND THAT THE SHEATH SEPARATION AT THE BLACK SECTION OBSERVED IN THE REPORTED EVENTS WAS ATTRIBUTED TO AN INSUFFICIENT BOND BETWEEN THE WHITE BODY OF THE OUTER SHEATH AND THE BLACK TIP. THE INSUFFICIENT BOND WAS FOUND TO BE DUE TO A COMBINATION OF MANUFACTURING MAINTENANCE EVENTS RESULTING IN A BENT MANDREL WITH MISSING BOTTOM BUSHING WHICH CREATED UNEVEN HEATING WITHIN THE REFLOW OVEN. THE INVESTIGATION FOUND THAT THE COMPLAINTS WERE ASSOCIATED WITH DEVICES MANUFACTURED FOLLOWING A CHANGE OF BOTTOM BUSHINGS ON (B)(6) 2023. A REVIEW OF MANUFACTURING MAINTENANCE ROUTINES, CALIBRATION ACTIVITIES, PROCESS CHANGES, MATERIALS, PERSONNEL, AND THE ENVIRONMENT RELATED TO THE REFLOW PROCESS WAS CONDUCTED AND CONCLUDED THAT THERE WERE NO ANOMALIES LIKELY TO CONTRIBUTE TO OUTER SHEATH SEPARATION AFTER (B)(6) 2024. IN (B)(6) 2024, BOSTON SCIENTIFIC INITIATED A VOLUNTARY PRODUCT REMOVAL ASSOCIATED WITH SPECIFIC LOTS OF THE HOT AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM (BSC REF. (B)(4)). THE REFERENCED DEVICE WAS IN SCOPE OF THIS PRODUCT REMOVAL. A CORRECTIVE ACTION (CAPA) INVESTIGATION HAS BEEN OPENED TO FURTHER INVESTIGATE THESE EVENTS TO DETERMINE ROOT CAUSE AND IDENTIFY CORRECTIVE ACTIONS THAT WILL ELIMINATE OR CONTROL THE CAUSE(S). THE CAPA IS ONGOING AND IS CURRENTLY IN THE SOLUTION PHASE WITH A TARGETED COMPLETION IN Q42025.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE ESOPHAGUS AND INTO THE STOMACH FOR THE TREATMENT OF CHOLEDOCOLITHIASIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE AXIOS STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, IT WAS OBSERVED THAT THE BLACK ENDOSCOPIC MARKER HAD DETACHED AND ADHERED TO THE STENT. THIS CAUSED THE SECOND FLANGE OF THE STENT TO REMAIN UNEXPANDED. ADDITIONALLY, THE DELIVERY SYSTEM GOT CAUGHT WITH THE UNEXPANDED STENT; HENCE, THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND THE BLACK MARKER WAS DETACHED, AND THE STENT WAS NOT FULLY EXPANDED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR AN EDGE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE ESOPHAGUS AND INTO THE STOMACH FOR THE TREATMENT OF CHOLEDOCOLITHIASIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE AXIOS STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, IT WAS OBSERVED THAT THE BLACK ENDOSCOPIC MARKER HAD DETACHED AND ADHERED TO THE STENT. THIS CAUSED THE SECOND FLANGE OF THE STENT TO REMAIN UNEXPANDED. ADDITIONALLY, THE DELIVERY SYSTEM GOT CAUGHT WITH THE UNEXPANDED STENT; HENCE, THE STENT WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND THE BLACK MARKER WAS DETACHED, AND THE STENT WAS NOT FULLY EXPANDED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR AN EDGE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1145831 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0034277686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |