AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2024-00876
- Event Type
- Injury
- Date Received
- March 4, 2024
- Date of Event
- February 13, 2024
- Report Date
- April 30, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- PMA / PMN Number
- K150692
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF TIP DETACHMENT. IMDRF PATIENT CODE E1108 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BILIARY LEAK. IMDRF IMPACT CODE F19 CAPTURES THE REVISION SURGERY FOR THE BILIARY LEAK. IMDRF IMPACT CODE F08 CAPTURES THE PATIENT'S PROLONGED HOSPITALIZATION.
BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF TIP DETACHMENT. IMDRF PATIENT CODE E1108 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BILIARY LEAK. IMDRF IMPACT CODE F19 CAPTURES THE REVISION SURGERY FOR THE BILIARY LEAK. IMDRF IMPACT CODE F08 CAPTURES THE PATIENT'S PROLONGED HOSPITALIZATION. BLOCK H10: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. VISUAL INSPECTION FOUND THAT THE OUTER SHEATH WAS KINKED INTO TWO SECTIONS AND THE CONTROL HUB WAS SLIGHTLY OPEN. MEDIA AND VISUAL ANALYSIS FOUND THAT THE TIP WITH THE INNER SHEATH WAS DETACHED. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT OF TIP DETACHMENT. HOWEVER, THE REPORTED EVENTS OF STENT FAILURE TO DEPLOY AND DEVICE ENTRAPMENT WERE NOT CONFIRMED BECAUSE THESE EVENTS OCCURRED DURING THE PROCEDURE AND WERE NOT POSSIBLE TO REPLICATE IN THE LABORATORY OF ANALYSIS. THE INVESTIGATION CONCLUDED THAT THE INNER SHEATH DETACHMENT AND THE CONTROL HUB BEING SLIGHTLY OPENED ARE MOST LIKELY PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, THE HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN TO FORCEFULLY REMOVE THE DEVICE, WHICH COULD HAVE RESULTED IN THE DAMAGES NOTED IN THE DEVICE. THEREFORE, TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE OVERALL ROOT CAUSE OF THE REPORTED EVENT IS AN ADVERSE EVENT RELATED TO THE PROCEDURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.
BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF TIP DETACHMENT. IMDRF PATIENT CODE E1108 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BILIARY LEAK. IMDRF IMPACT CODE F19 CAPTURES THE REVISION SURGERY FOR THE BILIARY LEAK. IMDRF IMPACT CODE F08 CAPTURES THE PATIENT'S PROLONGED HOSPITALIZATION. BLOCK H11: CORRECTION: THE CONTENT IN BLOCKS B5 AND H6 HAVE BEEN UPDATED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS, ACUTE CHOLECYSTITIS, AND BILIARY DUCT DILATION DURING A CHOLECYSTODUODENAL ANASTOMOSIS PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT'S FIRST FLANGE COULD NOT BE DEPLOYED AT ALL. UPON REMOVAL, WHEN THE PHYSICIAN WAS PULLING THE DEVICE THROUGH THE CHANNEL OF THE ENDOSCOPE, THE DISTAL PART OF THE CATHETER WHERE THE STENT WAS LOCATED BROKE AND WAS STUCK IN THE WORKING CHANNEL. THE BROKEN DISTAL PART OF THE CATHETER WAS REMOVED ALONG WITH THE SCOPE. THE PATIENT WAS SENT FOR REVISION SURGERY DUE TO A BILIARY LEAK AND WAS ALSO ADMITTED TO THE HOSPITAL BEYOND THE STANDARD DAYS OF CARE. NOTE: IT WAS REPORTED THAT THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM WAS USED TO TREAT CHOLEDOCHOLITHIASIS, ACUTE CHOLECYSTITIS, AND BILIARY DUCT DILATION DURING A CHOLECYSTODUODENAL ANASTOMOSIS PROCEDURE. PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY, AND THE BILE DUCT AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPH (ERCP) IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE STENT IS NOT INDICATED FOR CHOLEDOCHOLITHIASIS, ACUTE CHOLECYSTITIS, OR BILIARY DUCT DILATION DURING A CHOLECYSTODUODENAL ANASTOMOSIS PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS, ACUTE CHOLECYSTITIS, AND BILIARY DUCT DILATION DURING A CHOLECYSTODUODENAL ANASTOMOSIS PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT'S FIRST FLANGE COULD NOT BE DEPLOYED AT ALL. UPON REMOVAL, WHEN THE PHYSICIAN WAS PULLING THE DEVICE THROUGH THE CHANNEL OF THE ENDOSCOPE, THE DISTAL PART OF THE CATHETER WHERE THE STENT WAS LOCATED BROKE AND WAS STUCK IN THE WORKING CHANNEL. THE BROKEN DISTAL PART OF THE CATHETER WAS REMOVED ALONG WITH THE SCOPE. THE PATIENT WAS SENT FOR REVISION SURGERY DUE TO A BILIARY LEAK AND WAS ALSO ADMITTED TO THE HOSPITAL BEYOND THE STANDARD DAYS OF CARE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS, ACUTE CHOLECYSTITIS, AND BILIARY DUCT DILATION DURING A CHOLECYSTODUODENAL ANASTOMOSIS PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT'S FIRST FLANGE COULD NOT BE DEPLOYED AT ALL. UPON REMOVAL, WHEN THE PHYSICIAN WAS PULLING THE DEVICE THROUGH THE CHANNEL OF THE ENDOSCOPE, THE DISTAL PART OF THE CATHETER WHERE THE STENT WAS LOCATED BROKE AND WAS STUCK IN THE WORKING CHANNEL. THE BROKEN DISTAL PART OF THE CATHETER WAS REMOVED ALONG WITH THE SCOPE. THE PATIENT WAS SENT FOR REVISION SURGERY DUE TO A BILIARY LEAK AND WAS ALSO ADMITTED TO THE HOSPITAL BEYOND THE STANDARD DAYS OF CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177268 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | M00553550 | 0032254610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H| R |