MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553750
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h11: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f2301 captures the reportable event of the additional device required (clips) to close the puncture.
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 transgastric to facilitate a pseudocyst drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.Reportedly, the physician was using the eus method of deployment where the second flange of the stent is deployed in the scope, and then the stent is released from the scope by advancing the catheter and retracting the scope in a 1:1 fashion.During the procedure, the stent was deployed into the stomach, but the connection between the cyst and the stomach could not be completed.The stent was then removed partially deployed, and clips were placed to close the gastric perforation.The physician decided not to attempt placement of a second stent.It was reported that the patient experienced discomfort and pain due to the reported issue.However, the patient was sent home.There were no further complications reported.

• Brand Name: AXIOS?
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• 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 ; EI 01752 ; 9145716918
• MDR Report Key: 23769349
• Report Number: 3005099803-2025-06664
• Device Sequence Number: 9722746
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: (01)08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150692
• 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): 12/10/2025

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: M00553750
• Device Catalogue Number: M00553750
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/10/2025
• 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