MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios?; pancreatic stent, covered, metallic, removable

Model Number	M00553660
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific became aware of an event involving an axios stent and electrocautery enhanced delivery system through the article "retrieving a mis deployed lumen-apposing metal stent using a large-channel scope" by mark kowalczyk, et al.Per the article, a 72-year-old woman with recent necrotizing gallstone pancreatitis presented to the hospital with worsening abdominal pain.Computed tomography showed a 120 x 80-mm walled-off necrosis adjacent to the body of the pancreas.The stent was intended to be implanted transgastrically to the pancreas.During the procedure, following deployment, the stent was noted to have been deployed entirely within the pancreatic fluid collection.A second 20 x 10 mm lams was subsequently deployed at a new site under endoscopic and fluoroscopic guidance, and the stent was dilated to 15 mm.The initial puncture site was not closed, as the fluid collection was adherent to the gastric wall and spontaneous closure was anticipated without adverse outcomes.The misplaced stent was visualized within the collection, grasped with a snare, and successfully removed through the endoscope.Two double-pigtail stents were then placed between the gastric lumen and pancreatic cyst.Examination of the collection revealed residual necrosis with no adverse events observed.Please see the referenced article for full procedural details.
Additional Manufacturer Narrative
Block b3: approximated based on the date the article was received.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 such as the manufacture date.If additional details become available, a supplemental report will be submitted.Block g2: literature source: mark kowalczyk, et al.Retrieving a mis deployed lumen-apposing metal stent using a large-channel scope.Gastrointestinal endoscopy.Https://doi.Org/10.1016/j.Gie.2026.02.048 block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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 ; +1(914)571-6918
• MDR Report Key: 50885482
• Report Number: 3005099803-2026-03932
• Device Sequence Number: 10704852
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553660
• Device Catalogue Number: M00553660
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female