MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570380
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to the bile duct to treat a stricture caused by cancer during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The anatomy of the patient was tortuous but was not dilated prior to stent placement.Patient had elevated liver function.During the procedure, a stent deployment problem occurred.The device was removed using snares.The procedure was completed using another of the same device.There was no patient complications reported, and the patient has fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the use of additional device to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to the bile duct to treat a stricture caused by cancer during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) , 2026.The anatomy of the patient was tortuous but was not dilated prior to stent placement.Patient had elevated liver function.During the procedure, a stent deployment problem occurred.The device was removed using snares.The procedure was completed using another of the same device.There was no patient complications reported, and the patient has fully recovered.***additional information received on february 19, 2026*** the procedure performed did not cause the elevated liver function seen in the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the use of additional device to remove the stent.Block b5 and block h6 patient codes has been updated based on the additional information that was received on february 19, 2026.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.The device was not returned for analysis as it was contaminated; therefore, a technical analysis could not be performed.However, stent positioning issue is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the device was not returned for analysis as it was contaminated; therefore, a technical analysis could not be performed.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent positioning issue is noted within the instructions for use (ifu) as a known possible adverse event related to the use of the device.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24332649
• Report Number: 3005099803-2026-00587
• Device Sequence Number: 9791444
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: (01)08714729953197(17)260408(10)33782747
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 04/08/2026
• Device Model Number: M00570380
• Device Catalogue Number: M00570380
• Device Lot Number: 0033782747
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 04/08/2024
• 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