MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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	05/01/2023
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 all available information, boston scientific corporation did not confirm the reported event of stent failure to deploy as the stent was returned fully expanded and deployed.There is not enough evidence to determine the cause of this reported event.The investigation concluded that the additional observed damage of inner sheath kinked was most likely caused by procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied).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: an axios stent and electrocautery-enhanced delivery system was returned for analysis.During product analysis, the stent was observed to be fully expanded and deployed.Inspection of the stent identified no damage.The delivery system was returned in position 4 of the deployment process.Visual inspection identified the inner sheath was kinked and the outer sheath was buckled in the distal section near the black marker.No other damage was noted on the returned device.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 to be implanted trangasatric to pancreas to treat a pancreatic pseudocyst during an endoscopic ultrasound (eus) transluminal stent placing procedure performed on an unknown date during the procedure, the physician advanced the axios delivery catheter through a 3.7 mm working channel of a linear eus scope and positioned the device at the target site.Following the initial puncture, the physician attempted to deploy the stent; however, the stent would not deploy from the delivery catheter.The device was removed from the patient and replaced with another axios stent of the same model, which was used to successfully complete the procedure without further issue.There were no patient complications reported as a result of this event.

• Brand Name: AXIOS?
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 25144421
• Report Number: 3005099803-2026-01811
• Device Sequence Number: 18505009
• Product Code: KNS
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)241020(10)30394766
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2024
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0030394766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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