AXIOS
Report
- Report Number
- 3005099803-2024-06472
- Event Type
- Injury
- Date Received
- December 18, 2024
- Date of Event
- November 15, 2024
- Report Date
- January 13, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729904588
- PMA / PMN Number
- DEN230019
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS UNDER THE AGE OF 18. PRODUCT CODE: KNS, PCU, QXH; REPORTED HERE AS IT EXCEEDED THE MAXIMUM NUMBER OF CHARACTER LIMIT FOR THE DESIGNATED FIELD. PREMARKET/ 510(K): DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS IT EXCEEDED THE MAXIMUM NUMBER OF CHARACTER LIMIT FOR THE DESIGNATED FIELD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. : IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.
BLOCKS B5, H6 (IMPACT CODES) AND H11 WERE UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON DECEMBER 18, 2024. BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS UNDER THE AGE OF 18. BLOCK D2B: PRODUCT CODE: KNS, PCU, QXH; REPORTED HERE AS IT EXCEEDED THE MAXIMUM NUMBER OF CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/ 510(K): DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS IT EXCEEDED THE MAXIMUM NUMBER OF 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 H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF INTERVENTION PERFORMED TO REMOVE THE MIGRATED STENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING A PSEUDOCYST DRAINAGE WITH LUMEN APPOSING METAL STENT PLACEMENT (LAMS) PROCEDURE PERFORMED ON (B)(6) 2024. ON AN UNKNOWN DATE FOLLOWING A STENT PLACEMENT PROCEDURE, IT WAS NOTED THAT THE STENT HAD MIGRATED INTO THE MEDIASTINUM. REPORTEDLY, THE PHYSICIAN REPEATEDLY PASSED THE STENT WITH THEIR SCOPE, DESPITE HAVING ADVISED AGAINST THIS MANEUVER. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING A PSEUDOCYST DRAINAGE WITH LUMEN APPOSING METAL STENT PLACEMENT (LAMS) PROCEDURE PERFORMED ON (B)(6) 2024. ON AN UNKNOWN DATE FOLLOWING A STENT PLACEMENT PROCEDURE, IT WAS NOTED THAT THE STENT HAD MIGRATED INTO THE MEDIASTINUM. REPORTEDLY, THE PHYSICIAN REPEATEDLY PASSED THE STENT WITH THEIR SCOPE, DESPITE HAVING ADVISED AGAINST THIS MANEUVER. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 18, 2024. IT WAS REPORTED THAT THE STENT WAS REMOVED ONE WEEK POST STENT PLACEMENT, AND THE PHYSICIAN CHOSE NOT TO CLOSE THE PUNCTURE SITE. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1949690 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553640 | 08714729904588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |