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

Model Number	M00534600
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Perforation (2001); Biliary Leak (4820)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that two advanix biliary stent with naviflex rx delivery system were implanted in the common bile duct to treat stones and strictures during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2026.Reportedly, one of the two implanted plastic biliary stents migrated and the proximal end perforated the abdominal wall opposite to the papilla.As a result, there was biliary drainage into the peritoneal cavity.Yet no pneumoperitoneum was reported.The procedure was rescheduled to treat the perforation.No additional patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Block h11: investigation results: based on the information available, boston scientific could not confirm the reported events of stent migration and perforation.The product was not returned for analysis to identify any defect with the device.However, for the events of stent migration and perforation these adverse events are known and documented in the labeling and all reasonable steps have been taken (including both short or long term known complications or adverse reactions).On the other hand, for the events biliary leak and endoscopic procedure, they happened during the procedure, and the most probable cause of those reported issues cannot be established due to lack of evidence.Device history record review: 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: the complaint device was not returned; therefore, product analysis could not be performed.As a result, and due to the lack of available evidence, boston scientific was unable to confirm the reported event.Labeling review: a labeling review was performed using windchill.The ifu contains detailed device information and instructions for the device use.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: stent migration and perforation.Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review: a risk review was completed and confirmed that the events of stent migration and perforation were 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 cause not established.

• Brand Name: ADVANIX? BILIARY
• 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: 25354980
• Report Number: 3005099803-2026-02181
• Device Sequence Number: 9808327
• Product Code: FGE
• UDI-Device Identifier: 08714729787150
• UDI-Public: (01)08714729787150(17)270724(10)37986825
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203162
• 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
• Report Date (Section B): 06/01/2026

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: M00534600
• Device Catalogue Number: M00534600
• Device Lot Number: 0037986825
• 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: 05/05/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 07/24/2025
• 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 Sex: Unknown