MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios?; Gallbladder drainage stent and delivery system

Model Number	M00553680
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted in the common bile duct to treat a pancreatic head mass, which created an obstruction in the duodenum, during a choledochoduodenostomy procedure performed on (b)(6) 2025.During the procedure, the axios stent first flange did not open.The physician proceeded to steps 3 and 4, which were completed successfully.However, in the physician's assessment, the placement of the axios stent was not ideal, as the distal flange was slightly in the duodenum and there was a concern that it might have been in the peritoneal space, not fully in the common bile duct.A cannula was used to cannulate the stent, and a wire was passed through the stent with the intention to place a double pig-tail plastic stent to maintain access.Bile was observed draining from the axios stent, and the physician concluded that the distal flange was in the common bile duct and not in the peritoneal space.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was implanted in the common bile duct during a choledochoduodenostomy procedure.However, per the axios stent and electrocautery- enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts greater than or equal to 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris.The device is not indicated for placement in the common bile duct.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150101 captures the reportable event of stent first flange failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted in the common bile duct to treat a pancreatic head mass, which created an obstruction in the duodenum, during a choledochoduodenostomy procedure performed on (b)(6) 2025.During the procedure, the axios stent first flange did not open.The physician proceeded to steps 3 and 4, which were completed successfully.However, in the physician's assessment, the placement of the axios stent was not ideal, as the distal flange was slightly in the duodenum and there was a concern that it might have been in the peritoneal space, not fully in the common bile duct.A cannula was used to cannulate the stent, and a wire was passed through the stent with the intention to place a double pig-tail plastic stent to maintain access.Bile was observed draining from the axios stent, and the physician concluded that the distal flange was in the common bile duct and not in the peritoneal space.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the axios stent was implanted in the common bile duct during a choledochoduodenostomy procedure.However, per the axios stent and electrocautery- enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts greater than or equal to 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris.The device is not indicated for placement in the common bile duct.
Additional Manufacturer Narrative
Blocks h7 (if remedial act init, type), h9 (correction/removal reporting #), and h11 were updated.Blocks d2a (common device name) and d2b (pro code product code)), and g4 (premarket / 510(k) #) were corrected.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150101 captures the reportable event of stent first flange failure to expand.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.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: Gallbladder drainage stent and delivery system
• 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: 22581179
• Report Number: 3005099803-2025-03372
• Device Sequence Number: 15450087
• Product Code: QXH
• UDI-Device Identifier: 00191506008086
• UDI-Public: (01)00191506008086(17)260925(10)36165653
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2026

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 Expiration Date: 09/25/2026
• Device Model Number: M00553680
• Device Catalogue Number: M00553680
• Device Lot Number: 0036165653
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 07/02/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 01/14/2026; 07/27/2026
• Date Device Manufactured: 03/27/2025
• 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
• 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
• Patient Sex: Unknown