AXIOS
Report
- Report Number
- 3005099803-2024-06202
- Event Type
- Injury
- Date Received
- December 5, 2024
- Date of Event
- June 1, 2024
- Report Date
- December 5, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K233318
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS ON HER 50'S. BLOCK B3: EXACT EVENT DATE IS UNKNOWN; EVENT OCCURRED BETWEEN (B)(6) 2024 BLOCK D2B: PRODUCT CODE: KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. 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 A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE ADDITIONAL DEVICE USED TO COMPLETE THE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE BILE DUCT FOR THE TREATMENT OF A BILE LEAK DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED IN (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL FLANGE OF THE 20X10MM AXIOS DID NOT FULLY EXPAND AFTER DEPLOYMENT. THE PHYSICIAN SUBSEQUENTLY DEPLOYED THE PROXIMAL FLANGE. HOWEVER, AFTER FULLY DEPLOYING THE STENT, IT WAS NOTED UNDER IMAGING THAT THE DISTAL FLANGE STILL DID NOT FULLY EXPAND. THE PHYSICIAN THEN DECIDED TO PLACE A 15X15MM AXIOS STENT WITHIN THE LUMEN OF THE 20X10MM AXIOS STENT TO COMPLETE THE PROCEDURE. TWO WEEKS POST STENT PLACEMENT, THE 15X15MM AXIOS STENT WAS SUCCESSFULLY REMOVED; HOWEVER, THE 20X10MM AXIOS STENT WAS NOTED TO HAVE MOVED OUT OF ITS POSITION. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS PERFORMED, AND A PLASTIC STENT WAS PLACED THROUGH THE 20X10MM AXIOS STENT. FOUR WEEKS LATER, THE PLASTIC STENT WAS REMOVED TOGETHER WITH THE 20X10MM AXIOS STENT. THE FISTULA WHERE THE AXIOS HAD BEEN LOCATED WAS CLOSED WITH ENDOSCOPIC SUTURING. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A BILE LEAK DURING 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 TO BE PLACED FOR BILE LEAK. IT WAS REPORTED THAT THE SIZE OF THE SCOPE USED WAS 3.4 MM WORKING CHANNEL. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE WORKING CHANNEL OF THE SCOPE SHOULD BE 3.7MM OR LARGER. THE STENT IS NOT COMPATIBLE WITH A SCOPE WITH A WORKING CHANNEL SIZE OF 3.4 MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2290721 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553660 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |