MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553660
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent failure to deploy.Block h11: following an update to the axios risk documentation, this event is being reported as part of the efforts associated with boston scientific's nonconforming events and prevention investigation, (b)(4).Investigation result: with the information available, boston scientific concludes that the reported event involving failure of the stent to deploy could not be confirmed.The product was not returned and was disposed of at customer site, so a technical evaluation could not be performed to assess for potential defects.There is not enough evidence to determine whether the stent failure to deploy was due to the physician's technique during the procedure, due to the anatomical conditions or was related to a device malfunction.In addition, the manufacturing documentation review did not identify any issues that could be associated with the reported event.Therefore, the most probable cause of the event remains unknown.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of "stent failure to deploy" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
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 transgastric to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, at step 2 of the deployment, a snapping sound was noted inside the axios catheter.Subsequent attempts to deploy the stent were unsuccessful, as it did not exit the catheter.The physician tried to move the catheter control hub up and down several times in an effort to release the stent, but deployment could not be achieved.A wire was in place, allowing removal of the axios catheter.A second axios catheter was then advanced over the wire to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: AXIOS?
• 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: 25144854
• Report Number: 3005099803-2026-01817
• Device Sequence Number: 15797359
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: (01)08714729951179(17)241107(10)32811284
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K220112
• 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
• Report Date (Section B): 05/11/2026

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: 11/07/2024
• Device Model Number: M00553660
• Device Catalogue Number: M00553660
• Device Lot Number: 0032811284
• 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: 12/22/2023
• Initial Report FDA Received Date: 05/11/2026
• Date Device Manufactured: 11/08/2023
• 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