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

Model Number	M00553670
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the jejunum to treat a gastric outlet obstruction (pyloric stenosis) during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, the stent was attempted to be deployed, but the distal flange of the stent did not open.The physician adjusted the catheter and the position of the scope, and the stent eventually fully deployed; however, it deployed in the stomach and not across the stricture.The stent was removed with a snare and the procedure was completed using a different size axios stent.There was no patient complications reported as a result of this event.Note: it was reported that the axios stent was intended to be placed for a gastric outlet obstruction (pyloric stenosis).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 transduodenal to the jejunum.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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: 21973085
• Report Number: 3005099803-2025-01993
• Device Sequence Number: 17958306
• Product Code: KNS
• UDI-Device Identifier: 08714729979333
• UDI-Public: (01)08714729979333(17)270205(10)35785738
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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 Model Number: M00553670
• Device Catalogue Number: M00553670
• Device Lot Number: 0035785738
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 02/05/2025
• 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 Sex: Unknown