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

Model Number	M00553650
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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 results: with all available information, boston scientific corporation concludes that the reported event of stent failure to deploy was able to be confirmed.The device has been returned with the stent fully cover and undeployed, and the sheath was returned twisted.Additionally, the control hub was found detach from the outer sheath.These investigations findings could have unable to deploy the stent during the procedure.Most likely due to procedural factors such as lesion characteristics, handling of the device, or the technique used by the physician (force applied) that could have resulted in the damages encountered in the device.Device technical analysis: an axios stent and electrocautery-enhanced delivery system was received for analysis.The returned device contained the stent fully covered and undeployed; therefore, a functional inspection related to stent deployment could not be performed.The delivery system was received with the sheath appearing twisted.Additionally, the control hub was found detached from the outer sheath.The delivery system was subsequently disassembled to further assess the observed torsion.Upon disassembly, rotational damage was confirmed; however, the outer sheath itself was not found to be twisted.Device history record (dhr) review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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: taking all available information into consideration, the investigation concluded that the most probable cause is adverse event related to procedure.
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 pancreas to treat walled off necrosis (won) during an endoscopic ultrasound (eus) performed on (b)(6) 2024.During the procedure, the physician reported that the axios stent internal flange would not open.Additionally, the physician removed the stent and tried to deploy it outside the patient, but it would still not open.The stent as removed fully covered by the outer sheath and the procedure was able to be completed by using a cold axios stent.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: 25144862
• Report Number: 3005099803-2026-01823
• Device Sequence Number: 13106215
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)251104(10)32787806
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 11/04/2025
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0032787806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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