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

Model Number	M00534230
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was implanted in the common bile duct of a pediatric patient to treat an anastomotic stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Forty-eight hours after the stent placement procedure, the patient returned to the hospital and reported experiencing pain.A computed tomography (ct) scan was performed, and it was noted that the patient had perforation.The stent was also noted to have migrated through the duodenal wall.The patient was admitted to the hospital beyond standard of care after undergoing a reintervention procedure to close the perforation.In the physician's assessment, the duodenal perforation is related to the stent.The patient is expected to fully recover.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Block b3: exact event date is unknown; event occurred 48 hours post stent placement procedure.Block g4: premarket/510(k): k101314, k203162; reported here as this exceeded character limit for the designated field.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21043487
• Report Number: 3005099803-2024-06559
• Device Sequence Number: 12670364
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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: 08/09/2025
• Device Model Number: M00534230
• Device Catalogue Number: M00534230
• Device Lot Number: 0032193328
• 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: 12/04/2024
• Initial Report FDA Received Date: 12/30/2024
• Date Device Manufactured: 08/10/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose