AXIOS
Report
- Report Number
- 3005099803-2021-01522
- Event Type
- Injury
- Date Received
- April 7, 2021
- Date of Event
- March 4, 2021
- Report Date
- May 5, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K163272
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
BLOCK H6: MEDICAL DEVICE PROBLEM CODE A150201 CAPTURES THE REPORTABLE EVENT OF HOT AXIOS STENT FAILED TO DEPLOY IN THE STOMACH. BLOCK H10: A HOT AXIOS STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. THE STENT WAS RECEIVED FULLY COVERED BY THE OUTER SHEATH AND UNDEPLOYED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE OUTER SHEATH KINKED IN THE DISTAL SECTION. A DESTRUCTIVE INSPECTION WAS NECESSARY TO DESTROY THE DELIVERY SYSTEM; THE OUTER SHEATH WAS FOUND ACCORDIONED IN THE PROXIMAL SECTION (CLOSE TO THE HANDLE). MICROSCOPIC EXAMINATION WAS PERFORMED AND THE SIGNAL WIRE AND THE INNER SHAFT WERE KINKED IN THE DISTAL SECTION. FUNCTIONAL INSPECTION WAS PERFORMED AND THE STENT WAS ABLE TO DEPLOY WITHOUT PROBLEMS. NO OTHER ISSUES WITH THE STENT AND DELIVERY SYSTEM WERE NOTED. THE REPORTED EVENT OF STENT FAILURE TO DEPLOY WAS NOT CONFIRMED; DURING FUNCTIONAL EVALUATION, THE STENT WAS DEPLOYED WITHOUT PROBLEMS. 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. IT WAS REPORTED THAT THE AXIOS STENT WAS IMPLANTED IN THE STOMACH WHICH IS AN INCORRECT ANATOMICAL LOCATION ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. THE IFU STATES, "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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL". FURTHERMORE, IT WAS ALSO REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER THE IFU STATES, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." DURING ANALYSIS, THE OUTER SHEATH WAS ACCORDIONED NEAR THE LUER SECTION WHICH IS MOST LIKELY DUE TO THE INCORRECTLY ROTATED HANDLE. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT AND THE OBSERVED FAILURES WERE LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE. IT MAY BE THAT THE TECHNIQUES USED BY THE USER WHEN INSERTING THE DEVICE THROUGH THE SCOPE AND/OR ANATOMICAL FACTORS COULD HAVE INCREASED THE RESISTANCE AND FORCE USED, WHICH COULD HAVE CAUSED THE KINKS IN THE INNER SHEATH, OUTER SHEATH AND THE SIGNAL WIRE. THESE FAILURES MAY HAVE LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE STENT FAILURE TO DEPLOY. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. ANOTHER AXIOS STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER, PER HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE (DFU), "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED IN THE STOMACH. HOWEVER, PER THE HOT 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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE STOMACH.
(B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND WAS FULLY COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT. ANOTHER AXIOS STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER, PER HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE (DFU), "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED IN THE STOMACH. HOWEVER, PER THE HOT 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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE STOMACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525585 | AXIOS | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0026618141 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |