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	10/23/2023
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 pancreas to facilitate fluid collection during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, stent first flange did not deploy.The procedure was successfully completed using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.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, since the device has been returned with the stent fully covered and undeployed.Additionally, the outer sheath was returned twisted and detached.According to the investigation findings, the handle was rotated as the device was luer locked to the scope, and it is possible that the technique used by the physician rotating the handle incorrectly during the procedure could have caused the torsion in the delivery system leading to the rotational damaged, affecting its performance and could have unable to deploy the stent during procedure.Device technical analysis: an axios stent and electrocautery-enhanced delivery system was received for analysis.The device returned with the stent fully covered and undeployed and the outer sheath was returned twisted and detached.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.Labelling review: a labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use/product label.According to the information provided it was reported that the handle was rotated as the device was luer locked to the scope.The axios stent and electrocautery enhanced delivery system instructions for use state "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope it is possible that the technique used by the physician rotating the handle incorrectly during the procedure could have caused the torsion in the delivery system leading to the rotational damaged, affecting its performance and could have unable to deploy the stent during procedure.Risk review: a risk review was completed and confirmed that the event of "stent failure to deploy" was defined in the risk documentation and is documente.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 failure to follow instructions.

• 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: 25144419
• Report Number: 3005099803-2026-01807
• Device Sequence Number: 15782010
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)250831(10)32339495
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• 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: 08/31/2025
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0032339495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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