MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553570
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to june 01, 2025, as no event date was reported.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.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required to complete the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery systems was implanted in the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the axios stent deployed incorrectly into the pseudocyst.The device was apparently left implanted, and the procedure was completed with the use of an alternative method.However, the axios stent is scheduled to be explanted on (b)(6) 2025.There were no patient complications as a result of this event.No further information has been obtained despite good faith effort.
Additional Manufacturer Narrative
Block b5, d1, d2 and d4 has been updated with additional information received on october 01, 2025, block b3: date of event: date of event was approximated to june 01, 2025, as no event date was reported.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.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required to complete the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery systems was implanted in the pancreas to treat a pseudocyst during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the axios stent deployed incorrectly into the pseudocyst.The device was apparently left implanted, and the procedure was completed with the use of an alternative method.However, the axios stent is scheduled to be explanted on (b)(6) 2025.There were no patient complications as a result of this event.Additional information received on october 01, 2025.It was reported that the upn#m00553570.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED 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 ; 9145716918
• MDR Report Key: 22338989
• Report Number: 3005099803-2025-02864
• Device Sequence Number: 13051545
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: (01)08714729979333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: M00553570
• Device Catalogue Number: M00553570
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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