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	05/01/2024
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 transgastric to treat pancreatic pseudocyst during a pancreatic cystenterostomy procedure performed on an unknown date.During the procedure, the physician reported that the distal flange failed to deploy.Additionally, the physician tried to neutralize the scope, but it still did not work.The stent was removed fully covered by the outer sheath and 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.
Additional Manufacturer Narrative
Block b3: the event date was not provided, however may 1st, 2024, was selected as estimated date of event based on the bsc aware date.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.Only the delivery system was available for evaluation, and the inner sheath was returned kinked.There is not enough evidence to determine whether the stent failure to deploy was due to the physician's device manipulation during the procedure or related to a device malfunction.The additional investigation finding in the inner sheath could have occurred due to procedural factors such as excess of force or the manner as the device was handled and manipulated.Excessive manipulation of the device without enough care could have induced the defect found.Device technical analysis: an axios electrocautery enhanced delivery system was received for analysis.The stent associated with this complaint was not returned; only the delivery system was available for evaluation.During product analysis, the inner sheath of the delivery system was observed to be kinked.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: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25144870
• Report Number: 3005099803-2026-01821
• Device Sequence Number: 18486502
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)251207(10)33013794
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 12/07/2025
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0033013794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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