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	10/24/2024
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 not able to be confirmed since the device has been returned with the stent fully expanded and deployed.The cause could not be established.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: an axios stent with electrocautery enhanced delivery system was received for analysis.The stent was returned fully expanded and deployed.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 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 walled off necrosis (won) during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the physician reported that the axios stent failed to deploy.The procedure was able to be completed by using another of the same device.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: 25145254
• Report Number: 3005099803-2026-01843
• Device Sequence Number: 10752043
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: (01)08714729951179(17)250806(10)34577260
• 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: Other Health Care Professional
• 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: 08/06/2025
• Device Model Number: M00553660
• Device Catalogue Number: M00553660
• Device Lot Number: 0034577260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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