MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX? PANCREATIC STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00536560
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the pancreatic duct to treat chronic pancreatitis during a pancreatic duct stent placement.During the procedure, the stent could not be deployed.Upon inspection, the stent was found to be flattened.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: an advanix pancreatic stent and delivery system were received for analysis.Visual examination of the returned device found the stent deformed, the push catheter buckled accordion, and the guide catheter kinked.A media inspection was performed on a photo provided by the complainant, and it was found that the stent was deformed.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported events of stent failure to deploy and stent material deformation.The investigation concluded that the reported events and additional observed damages were most likely due to procedural factors encountered during the procedure.Factors such as the tortuosity of the procedure, the technique used by the physician, and the amount of force applied to the device, limited the performance of the device and contributed to the reported events and the observed damages.Taking all available information into consideration, the most probable cause of the reported events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the pancreatic duct to treat chronic pancreatitis during a pancreatic duct stent placement.During the procedure, the stent could not be deployed.Upon inspection, the stent was found to be flattened.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: ADVANIX? PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21518554
• Report Number: 3005099803-2025-00671
• Device Sequence Number: 8454927
• Product Code: FGE
• UDI-Device Identifier: 08714729857501
• UDI-Public: (01)08714729857501(17)250522(10)32899531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 05/22/2025
• Device Model Number: M00536560
• Device Catalogue Number: M00536560
• Device Lot Number: 0032899531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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