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); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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 intended to be implanted in the common bile duct (cbd) to facilitate drainage during a endoscopic ultrasound (eus) procedure performed on (b)(6) 2026.During the procedure, upon attempting to deploy the second flange of the axios in the target site, it did not deploy.The physician identified the issue, left wire in cbd and used another axios to successfully implant the device.The procedure was successfully 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 during a choledochoduodenostomy procedure.However, according to the axios stent and electrocautery-enhanced delivery system instructions for use, the stent is indicated for use to facilitate transgastric 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 between the common bile duct and the duodenum during a choledochoduodenostomy procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: the product investigation result is not yet complete at the time of submission of this report.A supplemental report will be submitted once it is finalized in order to communicate the findings of the investigation.

• 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: 24714446
• Report Number: 3005099803-2026-01128
• Device Sequence Number: 5763108
• Product Code: QXH
• UDI-Device Identifier: 00191506008086
• UDI-Public: (01)00191506008086(17)260603(10)35407589
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150692
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 06/03/2026
• Device Model Number: M00553680
• Device Catalogue Number: M00553680
• Device Lot Number: 0035407589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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