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

Model Number	M00553670
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's phone number is (b)(6); reported here as phone number exceeded character limit for designated field.Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a0501 captures the reportable event of tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was implanted for pseudocyst drainage during a cyst gastrostomy procedure performed on (b)(6) 2026.During the procedure, the axios stent was successfully deployed; however, resistance was encountered when the catheter was removed from the patient because the nose cone became caught on the elevator, causing the catheter to break off.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's phone number is (b)(6).Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h11: investigation results: based on the available information, boston scientific concludes that there is not enough evidence to determine if the reported events delivery system difficult to remove and tip detachment of device or device component were due to the physician's manipulation/technique during the procedure or related to a device malfunction.The device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: 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.Risk review: a review of the axios stent dfmea was completed and confirmed that the events of delivery system difficult to remove and tip detachment of device or device component were defined in the risk documentation.These event types have 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 unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was implanted for pseudocyst drainage during a cyst gastrostomy procedure performed on (b)(6) 2026.During the procedure, the axios stent was successfully deployed; however, resistance was encountered when the catheter was removed from the patient because the nose cone became caught on the elevator, causing the catheter to break off.There were no patient complications reported as a result of 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: 24407000
• Report Number: 3005099803-2026-00680
• Device Sequence Number: 8300350
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: (01)08714729979333(17)270829(10)37330330
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/19/2026

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: M00553670
• Device Catalogue Number: M00553670
• Device Lot Number: 0037330330
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 08/29/2025
• 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 Sex: Unknown