MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios?; unit, electrosurgical, endoscopic (with or without accessories)

Model Number	M00553680
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the reportable event of additional device required.Imdrf device code a15 captures the reportable event of stent partially deployed.
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 in the bile duct to facilitate a biliary drainage during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the physician had issues deploying the second flange, as it did not open properly while in scope position, resulting in unsuccessful deployment.An attempt was made to place the stent again, but it was ultimately removed.The stent was removed from the patient partially deployed.The procedure was completed by replacing and using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was intended to be implanted in the bile duct to facilitate a biliary drainage.However, according to the axios stent and electrocautery-enhanced delivery system instructions for use, the stent is indicated for use to facilitate trans gastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 6 cm or larger in size and walled-off necrosis 6 cm or larger in size with at least 70% fluid content, provided they are adherent to the gastric or bowel wall.The device is not indicated to be implanted in the bile duct to facilitate a biliary drainage.
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 in the bile duct to facilitate a biliary drainage during an endoscopic ultrasound (eus) procedure performed on an unknown date.During the procedure, the physician had issues deploying the second flange, as it did not open properly while in scope position, resulting in unsuccessful deployment.An attempt was made to place the stent again, but it was ultimately removed.The stent was removed from the patient partially deployed.The procedure was completed by replacing and using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was intended to be implanted in the bile duct to facilitate a biliary drainage.However, according to the axios stent and electrocautery-enhanced delivery system instructions for use, the stent is indicated for use to facilitate trans gastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 6 cm or larger in size and walled-off necrosis 6 cm or larger in size with at least 70% fluid content, provided they are adherent to the gastric or bowel wall.The device is not indicated to be implanted in the bile duct to facilitate a biliary drainage.
Additional Manufacturer Narrative
Blocks h7, h9 and h11 have been updated.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 impact code f2301 captures the reportable event of additional device required.Imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: boston scientific is initiating a removal of certain sizes of the axios stent and electrocautery enhanced delivery system (6mm x 8mm, 8mm x 8mm and 20mm x 10mm) manufactured since march 1, 2025.This action is being taken due to increased reports of stent deployment and expansion issues with these configurations.These issues only occur at the time of stent delivery and are expected to be noticed by the physician.Patients who have been treated with a successfully implanted axios stent should continue to follow standard of care and are not affected by this issue.A letter was sent out to materials managers/health care professionals on 19-dec-2025 to immediately stop further distribution or use of any affected 6mm x 8mm, 8mm x 8mm and 20mm x 10mm axios stent and electrocautery enhanced delivery system.The letter indicates to remove these devices from inventory and segregate them in a secure location until they can be returned to boston scientific.Despite multiple efforts, bsc was unable to confirm the batch number for the axios stent and electrocautery enhanced delivery system used in this event.Based on the reported clinical observations associated with failure to deploy and the date bsc was informed of this event, bsc is conservatively associating this event with the recall in an abundance of caution.The referenced axios stent and electrocautery enhanced delivery system met all specifications prior to final approval for distributions/sale.

• Brand Name: Axios?
• Common Device Name: unit, electrosurgical, endoscopic (with or without accessories)
• 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: 23132053
• Report Number: 3005099803-2025-04800
• Device Sequence Number: 8842818
• Product Code: KNS
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2026

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: M00553680
• Device Catalogue Number: M00553680
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 07/06/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 01/13/2026; 07/28/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-12192025-004-
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown