MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00553690
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Migration (4003)
Health Effect - Clinical Codes	Flatus (1865); Pain (1994); Perforation (2001)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: pro code (product code): pcu; reported here as this exceeded character limit for the designated field.Block g4: premarket/510(k): k233318; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a010402 captures the reportable event of stent migration imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent and close the puncture site.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was implanted to treat cholecystitis during a endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the first flange of the stent was slow to expand, but the physician was able to open it by manipulating the catheter.The procedure was completed using the original stent.One day after stent placement, the patient experienced pain.A computed tomography (ct) scan revealed that there is air and that the stent had migrated, with the distal flange located in the stomach and the proximal flange in the peritoneum.The stent was successfully removed, and two clips were placed to close the puncture site.The patient's condition improved following the removal of the stent.
Additional Manufacturer Narrative
Block h6 (patient codes) has been corrected.Block d2b: pro code (product code): pcu; reported here as this exceeded character limit for the designated field.Block g4: premarket/510(k): k233318; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a010402 captures the reportable event of stent migration imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent and close the puncture site.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was implanted to treat cholecystitis during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the first flange of the stent was slow to expand, but the physician was able to open it by manipulating the catheter.The procedure was completed using the original stent.One day after stent placement, the patient experienced pain.A computed tomography (ct) scan revealed that there is air and that the stent had migrated, with the distal flange located in the stomach and the proximal flange in the peritoneum.The stent was successfully removed, and two clips were placed to close the puncture site.The patient's condition improved following the removal of the stent.

• Brand Name: AXIOS
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21422528
• Report Number: 3005099803-2025-00535
• Device Sequence Number: 7641937
• Product Code: KNS
• UDI-Device Identifier: 00191506008093
• UDI-Public: 00191506008093
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: M00553690
• Device Catalogue Number: M00553690
• Device Lot Number: 0035388737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 11/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White