MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553640
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
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.In addition, the manufacturing documentation review did not identify any issues that could be associated with the reported event.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.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information, there is not enough evidence to confirm the reported event.Due to the lack of evidence and without proper evaluation of the complaint device, cause not established is selected as the investigation conclusion code.
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 transgastric to pancreas area to perform an eus pseudocyst drainage procedure performed on (b)(6) 2023.During the procedure, the physician experienced difficulty extending the catheter and deploying the stent.The device was prepared accordingly and passed through the scope.When the bottom lock was unlocked and the physician attempted to extend the catheter, it appeared to catch and did not extend smoothly.More force was required to incrementally extend the catheter.The device was removed from the scope, and the catheter was tested again, but the same issue persisted.The device was then retrieved, and the procedure was completed by using another axios stent of different size.There were no patient complications reported as a result of this event.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• 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: 25144399
• Report Number: 3005099803-2026-01793
• Device Sequence Number: 9316110
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)250326(10)31308468
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 03/26/2025
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0031308468
• 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: 08/18/2023
• Initial Report FDA Received Date: 05/11/2026
• Date Device Manufactured: 03/27/2023
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White