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

Model Number	M00534590
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
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 available information, boston scientific could not confirm the reported event of stent migration and perforation.The device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.However, stent migration and perforation is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.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 device was not returned for analysis as it remains implanted; therefore, a technical analysis could not be performed.Risk review: a risk review of the advanix biliary stents 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.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent migration and perforation are noted within the instructions for use (ifu) as a known possible adverse event related to the use of the device.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
Note: this report pertains to one of two advanix biliary stents with naviflex delivery systems used in the same patient.Refer to complaint id (b)(4) for the associated device information.It was reported to boston scientific corporation that two advanix biliary stents with naviflex delivery systems were implanted transduodenally to treat a suspected cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The advanix biliary stents were correctly implanted.However, on (b)(6) 2026, the patient presented to the emergency room; yet no symptoms were reported.On (b)(6) 2026, the patient underwent a computed tomography scan (ct), which revealed a perforated duodenum.Imaging also indicated that the stents had migrated distally from the intended implantation site.The patient was subsequently hospitalized and underwent surgery to repair the duodenal perforation.The stents were not explanted as a result of this adverse event and will remain in place until a scheduled explant procedure on (b)(6) 2026.

• 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: 24626711
• Report Number: 3005099803-2026-00989
• Device Sequence Number: 9015205
• Product Code: FGE
• UDI-Device Identifier: 08714729787143
• UDI-Public: (01)08714729787143(17)261023(10)35184430
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• 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): 03/18/2026

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: M00534590
• Device Catalogue Number: M00534590
• Device Lot Number: 0035184430
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 10/23/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown