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

Model Number	M00570380
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning problem.Imdrf patient code e1104 captures the event of patient exhibited an elevated liver function test result.Imdrf impact code f2301 captures the used of additional stent used to address the positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was implanted to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the physician experienced difficulty deploying the stent.Although the stent was eventually deployed, it migrated below the target location.The stent was removed from the patient, and the procedure was completed using another device.No patient complications were reported as a result of this event.However, the patient exhibited elevated liver function test results.
Additional Manufacturer Narrative
Blocks b5, h6 (patient codes), and h11 have been updated based on the additional information received on june 25, 2025.Block h6: imdrf device code a1502 captures the reportable event of stent positioning problem.Imdrf impact code f2301 captures the used of additional stent used to address the positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was implanted to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the physician experienced difficulty deploying the stent.Although the stent was eventually deployed, it migrated below the target location.The stent was removed from the patient, and the procedure was completed using another device.No patient complications were reported as a result of this event.However, the patient exhibited elevated liver function test results.Additional information received on june 25, 2025 the patient was reported to be symptomatic (exhibited elevated liver function test results) upon arrival at the facility.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was implanted to treat a biliary stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the physician experienced difficulty deploying the stent.Although the stent was eventually deployed, it migrated below the target location.The stent was removed from the patient, and the procedure was completed using another device.No patient complications were reported as a result of this event.However, the patient exhibited elevated liver function test results.Additional information received on june 25, 2025: the patient was reported to be symptomatic (exhibited elevated liver function test results) upon arrival at the facility.Additional information received on august 5, 2025: the stent was removed using a rat tooth forceps.Also, it was later clarified that the patient had no complications related to the event.
Additional Manufacturer Narrative
Blocks b5 has been updated based on the additional information received on august 5, 2025.Block h6: imdrf device code a1502 captures the reportable event of stent positioning problem.Imdrf impact code f2301 captures the used of additional stent used to address the positioning issue.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22286781
• Report Number: 3005099803-2025-02666
• Device Sequence Number: 12876344
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: (01)08714729953197(17)270123(10)35700190
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• 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,Followup,Followup
• Report Date (Section B): 08/26/2025

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: M00570380
• Device Catalogue Number: M00570380
• Device Lot Number: 0035700190
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 08/05/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/23/2025; 08/26/2025
• Date Device Manufactured: 01/23/2025
• 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