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

Model Number	M00534650
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 is being used to capture the reportable event of stent migration.Imdrf impact code f19 captures the surgical intervention to remove the stent.Imdrf patient code e2114 captures the reportable event of perforation.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex delivery system was implanted to treat jaundice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.A few days after the stent was implanted, it was noted that it migrated distally causing the patient a perforation.The stent has been subsequently explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Block b5 has been corrected.Block h6: imdrf device code a010402 is being used to capture the reportable event of stent migration.Imdrf impact code f19 captures the surgical intervention to remove the stent.Imdrf patient code e2114 captures the reportable event of perforation.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex delivery system was implanted in the left hepatic duct to treat jaundice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.A few days after the stent was implanted, it was noted that it migrated distally causing the patient a perforation.The stent has been subsequently explanted.No additional adverse patient effects were reported.

• 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: 21586829
• Report Number: 3005099803-2025-00788
• Device Sequence Number: 18446057
• Product Code: FGE
• UDI-Device Identifier: 08714729787204
• UDI-Public: (01)08714729787204
• 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: 2025
• 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): 04/30/2025

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: M00534650
• Device Catalogue Number: M00534650
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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