MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios Stent and Delivery System; pancreatic stent, covered, metallic, removable

Model Number	UNK-P-Cold_Axios
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150208 captures the reportable event of stent second flange stuck in scope.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.
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 treat a pseudocyst during a drainage procedure performed on (b)(6) 2026.During the procedure, the physician reported that the second flange did not deploy out of the scope.The physician tried to plunge and torque scope to the right but was unsuccessfully.The physician was able to complete the procedure by using another axios stent through the initial puncture site.There were no patient complications reported as a result of this event.

• Brand Name: Axios Stent and Delivery System
• 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 ; +1(914)571-6918
• MDR Report Key: 25630305
• Report Number: 3005099803-2026-02586
• Device Sequence Number: 13198861
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: (01)08714729904632
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: UNK-P-Cold_Axios
• Device Catalogue Number: UNK-P-Cold_Axios
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 07/05/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/29/2026
• 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
• Patient Sex: Unknown