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

Model Number	M00534720
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f2301 captures the reportable event of additional device required to address stent migration.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was implanted in the duodenal wall during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on an unknown date.Post stent placement, the advanix stent had migrated and perforated through the opposite side of the duodenal wall.
Additional Manufacturer Narrative
Blocks b5, block d4 (model number, lot number, catalog number, unique identifier (udi) #, expiration date), and h4 (device manufacture date) were updated based on the additional information received on april 22, 2025.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f2301 captures the reportable event of additional device required to address stent migration.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was implanted in the duodenal wall during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on an unknown date.Post stent placement, the advanix stent had migrated and perforated through the opposite side of the duodenal wall.Additional information received on april 22, 2025.This report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2025-01746 and 3005099803-2025-02157 for the associated device information.It was reported that two 10f pre-loaded advanix stents (subject of this report) and (subject of manufacturer report # 3005099803-2025-02157) were implanted bilaterally into the right and left hepatic ducts on (b)(6) 2024.Both of these devices had migrated causing perforation in the opposite wall of the duodenum.On (b)(6) 2024.The two advanix stents were removed using grasping forceps.The patient is currently well and is being re-assessed for treatment options for her likely cholangiocarcinoma which is peri hilar.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21903405
• Report Number: 3005099803-2025-01746
• Device Sequence Number: 19889165
• Product Code: FGE
• UDI-Device Identifier: 08714729787273
• UDI-Public: (01)08714729787273(17)260513(10)34521043
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/15/2025

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 Expiration Date: 05/13/2026
• Device Model Number: M00534720
• Device Catalogue Number: M00534720
• Device Lot Number: 0034521043
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 05/13/2024
• 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