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

Model Number	M00537300
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a150201 captures the reportable event of stent pigtail failed to curl/straighten after deployment.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the pancreatic duct during a pancreatic duct stent procedure performed on (b)(6) 2025.During the procedure, the stent was inserted into the pancreatic duct and deployment was attempted.However, the inner sheath could not be pulled, and deployment was unsuccessful.The advanix stent was then removed together with the delivery system, and it appeared that the pig tail part of the stent got lifted (failed to curl).The procedure was then completed using a non-boston scientific device.There was no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent pigtail failed to curl/straightened after deployment.Block h11: an advanix pancreatic stent and its delivery system were returned for analysis.Visual examination of the returned device found that the stent was damaged and undeployed.In addition, it was noted that the stent was stuck in the guide catheter.Functional test revealed that it was not possible to fully retract the pull wire because of the stent being stuck.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy due to the condition it was returned (damaged and undeployed).However, the reported event of stent pigtail failed to curl/straightened after deployment was not confirmed as product analysis of the returned device did not identify any evidence of this event.The investigation concluded that the additional observed event of stent damage was most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, taking all available information into consideration, the investigation concluded that the most probable cause of the 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 during a pancreatic duct stent procedure performed on (b)(6) 2025.During the procedure, the stent was inserted into the pancreatic duct and deployment was attempted.However, the inner sheath could not be pulled, and deployment was unsuccessful.The advanix stent was then removed together with the delivery system, and it appeared that the pig tail part of the stent got lifted (failed to curl).The procedure was then completed using a non-boston scientific device.There was no patient complications were reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the pancreatic duct during a pancreatic duct stent procedure performed on (b)(6) 2025.During the procedure, the stent was inserted into the pancreatic duct and deployment was attempted.However, the inner sheath could not be pulled, and deployment was unsuccessful.The advanix stent was then removed together with the delivery system, and it appeared that the pig tail part of the stent got lifted (failed to curl).The procedure was then completed using a non-boston scientific device.There was no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter zip/post code) and h11 have been corrected.Block e1 initial reporter zip/post code is (b)(6).Block h6: imdrf device code a150201 captures the reportable event of stent pigtail failed to curl/straighten after deployment.Block h11: an advanix pancreatic stent and its delivery system were returned for analysis.Visual examination of the returned device found that the stent was damaged and undeployed.In addition, it was noted that the stent was stuck in the guide catheter.Functional test revealed that it was not possible to fully retract the pull wire because of the stent being stuck.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy due to the condition it was returned (damaged and undeployed).However, the reported event of stent pigtail failed to curl/straighten after deployment was not confirmed as product analysis of the returned device did not identify any evidence of this event.The investigation concluded that the additional observed event of stent damage was most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, taking all available information into consideration, the investigation concluded that the most probable cause of the events is adverse event related to procedure.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22106872
• Report Number: 3005099803-2025-02470
• Device Sequence Number: 20652083
• Product Code: FGE
• UDI-Device Identifier: 08714729856894
• UDI-Public: (01)08714729856894(17)260124(10)34510861
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 01/24/2026
• Device Model Number: M00537300
• Device Catalogue Number: M00537300
• Device Lot Number: 0034510861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 10/21/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/22/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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