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

Model Number	M00553750
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.The device was not returned for analysis; therefore, a technical analysis could not be performed.There is not enough evidence to determine whether the reported event was due to the physician's manipulation or technique during the procedure or related to a device malfunction.Device history record review: a review of the manufacturing documentation was unable to be performed as the required device documentation was unavailable.Device technical analysis: the device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.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 implanted in the pancreas to facilitate pancreatic fluid collection (pfc) during a cystogastrostomy procedure performed on (b)(6).Reportedly, the physician appropriately identified the pfc via medical imaging.The target was visualized and the stent was deployed.After deployment, the physician suspected that the stent may have been placed into the gallbladder rather than the intended pfc.The stent was reported to be currently implanted.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: 24620092
• Report Number: 3005099803-2026-00993
• Device Sequence Number: 9585856
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: (01)08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/17/2026

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 Model Number: M00553750
• Device Catalogue Number: M00553750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/17/2026
• 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