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

Model Number	M00553640
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	11/17/2023
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 results: based on the available information, boston scientific corporation could not confirm the reported event of stent failure to deploy, the stent was not returned for product evaluation.The investigation concluded that the additional observed event of inner sheath kinked was most likely caused by procedural factors such as lesion characteristics, handling of the device and the technique used by the physician (force applied).It is possible that the observed damage may have contributed to the inability to deploy the stent during the procedure.Device history record: 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 electrocautery enhanced delivery system was received for analysis; the axios stent was not.Visual examination of the returned device found the inner sheath was kinked.No other problems were noted with the delivery system.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 no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted in the stomach to treat a pancreatic cyst ppc during a pancreatic cyst gastric bypass procedure performed on (b)(6) 2023.During the procedure, the axios stent did not deploy.The device was removed, and another axios stent was used to complete the procedure.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: 25144321
• Report Number: 3005099803-2026-01745
• Device Sequence Number: 9406818
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)250730(10)32117718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• 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: 07/30/2025
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0032117718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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