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

Model Number	M00553650
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.The complaint device was not returned as it was discarded; therefore, product analysis could not be performed.Stent positioning issue is also noted within the ifu as a possible adverse event associated with the use of the device.Device history records review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the complaint device was not returned as it was discarded; therefore, product analysis could not be performed.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent positioning issue is noted within the instructions for use (ifu) as a known possible adverse event related to the use of the device.Risk review: a risk review was completed and confirmed that the reported event of stent positioning issue was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2026.During the procedure, the distal flange deployed successfully; however, the proximal flange could not be deployed despite full advancement of the deployment hub.The physician attempted multiple manipulations to facilitate deployment; however, the stent was inadvertently fully deployed into the cystic collection.Using guidewire access, a second axios stent was placed through the initially deployed axios stent to act as a tunnel and facilitate transgastric drainage.There were no patient complications reported due to this event.

• 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 ; 9145716918
• MDR Report Key: 25353413
• Report Number: 3005099803-2026-02249
• Device Sequence Number: 10748566
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)280318(10)38873800
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220112
• 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): 06/01/2026

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: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0038873800
• 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: 05/08/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 03/19/2026
• 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