AXIOS?
Report
- Report Number
- 3005099803-2024-06476
- Event Type
- Injury
- Date Received
- December 18, 2024
- Date of Event
- November 22, 2024
- Report Date
- April 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729904595
- PMA / PMN Number
- K233318
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF INNER SHEATH DETACHED. IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF SHEATH BLACK MARKER SEPARATION. IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. BLOCK H11: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS. HOWEVER, SAMPLE PHOTOS WERE PROVIDED WHERE IT CAN BE OBSERVED THE DEVICE WITH EVIDENCE OF INNER SHAFT/SHEATH DETACHMENT, THE BLACK MARKER DETACHED (SHEATH MATERIAL SEPARATION) AND THE STENT'S EXPANSION HINDERED BY THE DETACHED BLACK MARKER. WITH THE SAMPLE PHOTOS PROVIDED, THE PRODUCT ANALYSIS CONFIRMED ALL THE REPORTED EVENTS. HOWEVER, THE INVESTIGATION CONCLUDED THAT FOR THE REPORTED EVENTS OF STENT DIFFICULT TO DEPLOY AND INNER SHAFT/SHEATH DETACHMENT OF DEVICE OR DEVICE COMPONENT THE EVIDENCE PROVIDED IS NOT SUFFICIENT TO DETERMINE IF THESE WERE RELATED TO PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE OR WAS RELATED TO A DEVICE MALFUNCTION. 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. 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 DECEMBER 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 JANUARY 28, 2024. IN DECEMBER 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 AND PREVENTIVE ACTION (CAPA) INVESTIGATION 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.
TAB A. PATIENT INFORMATION HAS BEEN UPDATED WITH ADDITIONAL PATIENT DETAILS RECEIVED ON JANUARY 03, 2025. BLOCK D2B: PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF INNER SHEATH DETACHED. IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF SHEATH BLACK MARKER SEPARATION. IMDRF DEVICE CODE A150101CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. BLOCK H11: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS. HOWEVER, SAMPLE PHOTOS WERE PROVIDED WHERE IT CAN BE OBSERVED THE DEVICE WITH EVIDENCE OF INNER SHAFT/SHEATH DETACHMENT, THE BLACK MARKER DETACHED (SHEATH MATERIAL SEPARATION) AND THE STENT'S EXPANSION HINDERED BY THE DETACHED BLACK MARKER. WITH THE SAMPLE PHOTOS PROVIDED, THE PRODUCT ANALYSIS CONFIRMED ALL THE REPORTED EVENTS. HOWEVER, THE INVESTIGATION CONCLUDED THAT FOR THE REPORTED EVENTS OF STENT DIFFICULT TO DEPLOY AND INNER SHAFT/SHEATH DETACHMENT OF DEVICE OR DEVICE COMPONENT THE EVIDENCE PROVIDED IS NOT SUFFICIENT TO DETERMINE IF THESE WERE RELATED TO PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE OR WAS RELATED TO A DEVICE MALFUNCTION. 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 AND PREVENTIVE ACTION (CAPA) INVESTIGATION 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.
TAB A. PATIENT INFORMATION HAS BEEN UPDATED WITH ADDITIONAL PATIENT DETAILS RECEIVED ON JANUARY 03, 2025. BLOCK D2B: PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF INNER SHEATH DETACHED. IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF SHEATH BLACK MARKER SEPARATION. IMDRF DEVICE CODE A150101CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE BLACK MARKER RETURNED IN THE STENT SADDLE, DETACHED FROM THE DELIVERY SYSTEM. IT WAS ALSO OBSERVED THAT THE INNER SHEATH WAS RETURNED DETACHED AND KINKED. NO OTHER PROBLEMS WERE NOTED WITH THE STENT OR THE DELIVERY SYSTEM. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENTS OF INNER SHAFT/SHEATH DETACHMENT OF DEVICE OR DEVICE COMPONENT, SHEATH MATERIAL SEPARATION AND STENT FAILURE TO EXPAND AS THE BLACK MARKER RETURNED IN THE STENT SADDLE, DETACHED FROM THE DELIVERY SYSTEM. THE INVESTIGATION CONCLUDED THAT REPORTED EVENT OF STENT DIFFICULT TO DEPLOY CANNOT BE CONFIRMED BECAUSE IT HAPPENED DURING THE PROCEDURE, AND IT IS NOT POSSIBLE TO REPLICATE IT IN THE LABORATORY OF ANALYSIS. IN ADDITION, THE OBSERVED PROBLEM OF INNER SHEATH KINKED MOST LIKELY OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), THAT LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE OBSERVED PROBLEM. 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. 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 DECEMBER 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 JANUARY 28, 2024. IN DECEMBER 2024, BOSTON SCIENTIFIC INITIATED A VOLUNTARY PRODUCT REMOVAL ASSOCIATED WITH SPECIFIC LOTS OF THE HOT AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM (BSC REF. 9732248). THE REFERENCED DEVICE WAS IN SCOPE OF THIS PRODUCT REMOVAL. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION 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 D2B: PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF INNER SHEATH DETACHED. IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF SHEATH BLACK MARKER SEPARATION. IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE PANCREAS TO TREAT A PSEUDOCYST DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. THE PHYSICIAN WAS USING BOTH THE EUS METHOD OF DEPLOYMENT AND DIRECT ENDOSCOPIC VISUALIZATION METHOD. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED; HOWEVER, UPON DEPLOYING THE SECOND FLANGE, THE BLACK MARKER ON THE OUTER CATHETER SLIPPED OFF AND OVER THE SADDLE OF THE STENT. THIS RESULTED TO THE SADDLE BECOMING CONSTRAINED WITHIN THE ANASTOMOSIS WHICH ALSO CAUSED THE INNER CATHETER AND NOSE CONE TO BECOME STUCK IN THE SADDLE. THE PHYSICIAN WAS ABLE TO MANEUVER THE SCOPE TO RELEASE THE STENT; HOWEVER, THE INNER CATHETER BROKE. THE STENT WAS PLACED IN THE CORRECT POSITION AND WAS ABLE TO FULLY DRAIN. THE INNER CATHETER THAT BROKE OFF REMAINED INSIDE THE STENT AND THE PATIENT. THE STENT WAS EVENTUALLY REMOVED ON (B)(6) 2024, WITHOUT LEAVING BEHIND ANY DEVICE FRAGMENTS, AND IT HAS BEEN REPORTED THAT THE CYST WAS ABLE TO COMPLETELY DRAIN. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT STATUS WAS REPORTED TO BE DOING WELL. NOTE: THE COMPLAINANT PROVIDED A PHOTO OF THE DEVICE, SHOWING A FULLY DEPLOYED STENT OUTSIDE THE PATIENT, WITH THE BLACK MARKER POSITIONED OVER THE SADDLE OF THE STENT. ADDITIONALLY, THE AXIOS STENT CONTAINED A BROKEN INNER SHEATH. THE STENT APPEARED UNEXPANDED, LIKELY DUE TO THE BLACK MARKER'S PLACEMENT OVER THE SADDLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE PANCREAS TO TREAT A PSEUDOCYST DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. THE PHYSICIAN WAS USING BOTH THE EUS METHOD OF DEPLOYMENT AND DIRECT ENDOSCOPIC VISUALIZATION METHOD. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED; HOWEVER, UPON DEPLOYING THE SECOND FLANGE, THE BLACK MARKER ON THE OUTER CATHETER SLIPPED OFF AND OVER THE SADDLE OF THE STENT. THIS RESULTED TO THE SADDLE BECOMING CONSTRAINED WITHIN THE ANASTOMOSIS WHICH ALSO CAUSED THE INNER CATHETER AND NOSE CONE TO BECOME STUCK IN THE SADDLE. THE PHYSICIAN WAS ABLE TO MANEUVER THE SCOPE TO RELEASE THE STENT; HOWEVER, THE INNER CATHETER BROKE. THE STENT WAS PLACED IN THE CORRECT POSITION AND WAS ABLE TO FULLY DRAIN. THE INNER CATHETER THAT BROKE OFF REMAINED INSIDE THE STENT AND THE PATIENT. THE STENT WAS EVENTUALLY REMOVED ON (B)(6) 2024, WITHOUT LEAVING BEHIND ANY DEVICE FRAGMENTS, AND IT HAS BEEN REPORTED THAT THE CYST WAS ABLE TO COMPLETELY DRAIN. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT STATUS WAS REPORTED TO BE DOING WELL. NOTE: THE COMPLAINANT PROVIDED A PHOTO OF THE DEVICE, SHOWING A FULLY DEPLOYED STENT OUTSIDE THE PATIENT, WITH THE BLACK MARKER POSITIONED OVER THE SADDLE OF THE STENT. ADDITIONALLY, THE AXIOS STENT CONTAINED A BROKEN INNER SHEATH. THE STENT APPEARED UNEXPANDED, LIKELY DUE TO THE BLACK MARKER'S PLACEMENT OVER THE SADDLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE PANCREAS TO TREAT A PSEUDOCYST DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. THE PHYSICIAN WAS USING BOTH THE EUS METHOD OF DEPLOYMENT AND DIRECT ENDOSCOPIC VISUALIZATION METHOD. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED; HOWEVER, UPON DEPLOYING THE SECOND FLANGE, THE BLACK MARKER ON THE OUTER CATHETER SLIPPED OFF AND OVER THE SADDLE OF THE STENT. THIS RESULTED TO THE SADDLE BECOMING CONSTRAINED WITHIN THE ANASTOMOSIS WHICH ALSO CAUSED THE INNER CATHETER AND NOSE CONE TO BECOME STUCK IN THE SADDLE. THE PHYSICIAN WAS ABLE TO MANEUVER THE SCOPE TO RELEASE THE STENT; HOWEVER, THE INNER CATHETER BROKE. THE STENT WAS PLACED IN THE CORRECT POSITION AND WAS ABLE TO FULLY DRAIN. THE INNER CATHETER THAT BROKE OFF REMAINED INSIDE THE STENT AND THE PATIENT. THE STENT WAS EVENTUALLY REMOVED ON (B)(6) 2024, WITHOUT LEAVING BEHIND ANY DEVICE FRAGMENTS, AND IT HAS BEEN REPORTED THAT THE CYST WAS ABLE TO COMPLETELY DRAIN. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT STATUS WAS REPORTED TO BE DOING WELL. NOTE: THE COMPLAINANT PROVIDED A PHOTO OF THE DEVICE, SHOWING A FULLY DEPLOYED STENT OUTSIDE THE PATIENT, WITH THE BLACK MARKER POSITIONED OVER THE SADDLE OF THE STENT. ADDITIONALLY, THE AXIOS STENT CONTAINED A BROKEN INNER SHEATH. THE STENT APPEARED UNEXPANDED, LIKELY DUE TO THE BLACK MARKER'S PLACEMENT OVER THE SADDLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE PANCREAS TO TREAT A PSEUDOCYST DURING A CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. THE PHYSICIAN WAS USING BOTH THE EUS METHOD OF DEPLOYMENT AND DIRECT ENDOSCOPIC VISUALIZATION METHOD. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS DEPLOYED; HOWEVER, UPON DEPLOYING THE SECOND FLANGE, THE BLACK MARKER ON THE OUTER CATHETER SLIPPED OFF AND OVER THE SADDLE OF THE STENT. THIS RESULTED TO THE SADDLE BECOMING CONSTRAINED WITHIN THE ANASTOMOSIS WHICH ALSO CAUSED THE INNER CATHETER AND NOSE CONE TO BECOME STUCK IN THE SADDLE. THE PHYSICIAN WAS ABLE TO MANEUVER THE SCOPE TO RELEASE THE STENT; HOWEVER, THE INNER CATHETER BROKE. THE STENT WAS PLACED IN THE CORRECT POSITION AND WAS ABLE TO FULLY DRAIN. THE INNER CATHETER THAT BROKE OFF REMAINED INSIDE THE STENT AND THE PATIENT. THE STENT WAS EVENTUALLY REMOVED ON (B)(6) 2024, WITHOUT LEAVING BEHIND ANY DEVICE FRAGMENTS, AND IT HAS BEEN REPORTED THAT THE CYST WAS ABLE TO COMPLETELY DRAIN. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT STATUS WAS REPORTED TO BE DOING WELL. NOTE: THE COMPLAINANT PROVIDED A PHOTO OF THE DEVICE, SHOWING A FULLY DEPLOYED STENT OUTSIDE THE PATIENT, WITH THE BLACK MARKER POSITIONED OVER THE SADDLE OF THE STENT. ADDITIONALLY, THE AXIOS STENT CONTAINED A BROKEN INNER SHEATH. THE STENT APPEARED UNEXPANDED, LIKELY DUE TO THE BLACK MARKER'S PLACEMENT OVER THE SADDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361251 | AXIOS? | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553650 | 0034065578 | 08714729904595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |