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

Model Number	M00553640
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was intended to be implanted in a procedure performed on (b)(6) 2026.During the procedure, the physician reported that the second portion of the stent would not deploy.Additionally, it was reported that the first portion did deploy.The physician had to remove the stent and redeploy another axios stent of a different size.There were no patient complications reported as a result of this event and the patient made a full recovery.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25145258
• Report Number: 3005099803-2026-01847
• Device Sequence Number: 18829306
• Product Code: KNS
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)270520(10)36564439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0036564439
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/04/2026
• Date Device Manufactured: 05/20/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 112 KG