AXIOS
Report
- Report Number
- 3005099803-2024-06353
- Event Type
- Injury
- Date Received
- December 12, 2024
- Date of Event
- November 15, 2024
- Report Date
- January 8, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K163272
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- 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/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY DURING A GASTROJEJUNOSTOMY PROCEDURE.
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/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY DURING A GASTROJEJUNOSTOMY PROCEDURE. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT FULLY EXPANDED AND DEPLOYED, AND THE INNER SHEATH WAS KINKED. NO OTHER PROBLEMS WERE NOTED WITH THE STENT AND DELIVERY SYSTEM. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY AS THE STENT WAS RETURNED FULLY EXPANDED AND DEPLOYED. THE OBSERVED PROBLEM OF INNER SHEATH KINKED MOST LIKELY OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE OBSERVED PROBLEM. THERE IS NO INDICATION OF WHAT THE CUSTOMER REPORTED BECAUSE THE STENT WAS RETURNED FULLY EXPANDED AND DEPLOYED. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS NO PROBLEM DETECTED. 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 AXIOS STENT WAS INTENDED TO BE PLACED FOR A GASTROJEJUNOSTOMY PROCEDURE. 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 THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL."
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT#: 3005099803-2024-06352 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE JEJUNUM TO TREAT A GASTRIC OBSTRUCTION DUE TO MALIGNANCY DURING A GASTROJEJUNOSTOMY PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE PHYSICIAN ADVANCED AND RETRACTED THE CATHETER IN AN ATTEMPT TO DEPLOY THE STENT, BUT IT WAS STILL UNABLE TO BE DEPLOYED. A SECOND AXIOS STENT WAS USED, BUT THE SAME ISSUE OCCURRED. A THIRD AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR A GASTROJEJUNOSTOMY 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 PLACEMENT TRANSGASTRIC TO THE JEJUNUM.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-06353 AND 3005099803-2024-06352 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE JEJUNUM TO TREAT A GASTRIC OBSTRUCTION DUE TO MALIGNANCY DURING A GASTROJEJUNOSTOMY PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE PHYSICIAN ADVANCED AND RETRACTED THE CATHETER IN AN ATTEMPT TO DEPLOY THE STENT, BUT IT WAS STILL UNABLE TO BE DEPLOYED. A SECOND AXIOS STENT WAS USED, BUT THE SAME ISSUE OCCURRED. A THIRD AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR A GASTROJEJUNOSTOMY 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 PLACEMENT TRANSGASTRIC TO THE JEJUNUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2416075 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0033846518 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |