MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM

Model Number	M00553690
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the gallbladder for a gallbladder drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6), 2025.During the procedure, the first flange was attempted to be deployed; however, it was not visualized under eus.Minor hemorrhage was observed that was tamponade until it stopped on its own.The catheter and the scope were subsequently retracted from the patient to observe the stent, and it was noticed the flange had not deployed.Deployment was re-attempted outside of the patient to see what was happening with the device, and the stent completely flew out of the catheter.The procedure was aborted, and a new axios stent was implanted 2 days later to let the patient rest.There were no additional patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf impact code f1001 captures the reportable event of the procedure was aborted.Imdrf impact code f2301 captures the reportable event of the device used to tamponade the bleeding.Imdrf impact code f2301 captures the reportable event of the patient hospitalization for two days while waiting for the new implant procedure.Imdrf impact code f2202 captures the reportable event of the endoscopic procedure to get the new axios stent implanted 2 days later.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number; therefore, the device manufacture date is unknown at this time.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150101 captures the reportable event of stent first flange failure to expand.Block h7 and h9: added type of remedial action and the correction/removal reporting # information.Block h11: the batch information was not provided for this event, and bsc cannot confirm if the device used is within scope of the recall.This event was conservatively associated to the recall.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 expand 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.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted during a choledocho-duodenostomy procedure performed on (b)(6) 2025.During the procedure, the axios distal flange was not opening.There were no patient complications reported as a result of this event.

• 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 ; 9145716918
• MDR Report Key: 23889513
• Report Number: 3005099803-2025-06888
• Device Sequence Number: 15818733
• Product Code: QXH
• UDI-Device Identifier: 00191506008093
• UDI-Public: (01)00191506008093(17)270422(10)37764852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: M00553690
• Device Catalogue Number: M00553690
• Device Lot Number: 0037764852
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 10/22/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Race: Native Hawaiian Or Other Pacific Islander