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

Model Number	M00534570
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2202 captures the reportable event of endoscopic procedure performed to remove the migrated stent.Imdrf impact code f2201 captures the additional device required that replaced the migrated stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was implanted in the left intrahepatic duct (ihd) to treat jaundice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.There was no serious injury reported and the patient's condition following the procedure was reported to be stable.Several days after the initial implantation, the patient experienced pain, and the patient's bilirubin levels did not decrease as expected.On (b)(6) 2025, a subsequent ercp was performed, which confirmed distal stent migration.The original stent was removed and replaced with a non-boston scientific stent.No extended observation period was required, and the patient's current condition was reported to be fine.

• 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: 24218181
• Report Number: 3005099803-2026-00363
• Device Sequence Number: 9265633
• Product Code: FGE
• UDI-Device Identifier: 08714729787129
• UDI-Public: (01)08714729787129(17)260116(10)33226755
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K203162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 01/29/2026

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 Expiration Date: 01/16/2026
• Device Model Number: M00534570
• Device Catalogue Number: M00534570
• Device Lot Number: 0033226755
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 01/17/2024
• 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: Required Intervention
• Patient Sex: Unknown