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

Model Number	M00534290
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to (b)(4) corporation that an advanix biliary stent with naviflex delivery system was implanted during a procedure performed on an unknown date.Post-procedure during an emergent follow-up, it was noticed that the advanix stent migrated distally and caused a perforation on the opposing duodenal wall.Reportedly, the stent was removed.The patient condition after removal was not reported.
Additional Manufacturer Narrative
Block b3: event date has been approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code (b)(6) captures the reportable event of perforation.Imdrf impact code f2202 captures the reportable event of the emergent endoscopic procedure to retrieve the migrated stent.Imdrf impact code f2301 captures the reportable event of an additional device required to retrieve the migrated stent.

• Brand Name: ADVANIX? BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23536461
• Report Number: 3005099803-2025-05696
• Device Sequence Number: 10074187
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101314
• 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): 11/12/2025

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: M00534290
• Device Catalogue Number: M00534290
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/12/2025
• 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