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

Model Number	M00534270
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001); Discomfort (2330)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted in the common bile duct to treat an obstruction caused by bile duct stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Four weeks after the procedure, the patient presented to the emergency department with pain and discomfort.The physician conducted an endoscopic procedure and found that the implanted advanix biliary stent had migrated and perforated the lumen of the duodenal wall.It was observed that half of the stent had penetrated through.Reportedly, the bile duct stones measured approximately 1 cm in size.The physician then removed the stent using snares and closed the fistula using resolution clips.Following the stent removal, the patient remained in the hospital for one week to undergo another ercp procedure to remove the stones, which involved implanting another advanix biliary stent.The condition of the patient was reported to have fully recovered.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event of stent migration.

• 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
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 23069118
• Report Number: 3005099803-2025-04624
• Device Sequence Number: 15963582
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: (01)08714729787365
• 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): 09/16/2025

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: M00534270
• Device Catalogue Number: M00534270
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/16/2025
• 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