MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY PLUS RX STENT SYSTEM; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	M00547540
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates; and complete udi information are unknown.Block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf impact code f2301 captures the reportable event of an additional device required to remove the stent.
Event or Problem Description
It was reported that a wallflex biliary plus fully covered stent was implanted to treat a stricture during a endoscopic retrograde cholangiopancreatography performed on (b)(6) 2025.On (b)(6) 2025 the physician explanted the stent because it was causing too much pressure on the biliary duct resulting on pancreatitis in the patient.It is unknown if another stent was implanted as replacement of this device.No additional patient complications were reported due to this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates; and complete udi information are unknown.Block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf impact code f2301 captures the reportable event of an additional device required to remove the stent.
Event or Problem Description
It was reported that a wallflex biliary plus fully covered stent was implanted to treat a stricture during a endoscopic retrograde cholangiopancreatography performed on (b)(6) 2025.On (b)(6) 2025 the physician explanted the stent because it was causing too much pressure on the biliary duct resulting on pancreatitis in the patient.It is unknown if another stent was implanted as replacement of this device.No additional patient complications were reported due to this event.***additional information received on may 12, 2025**** it was reported to boston scientific corporation that a wallflex biliary plus fully covered stent was to be implanted to treat a stricture in the bile duct during an endoscopic retrograde cholangiopancreatography performed on (b)(6) 2025.

• Brand Name: WALLFLEX BILIARY PLUS RX STENT SYSTEM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 22062867
• Report Number: 3005099803-2025-02178
• Device Sequence Number: 7634417
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2025

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: M00547540
• Device Catalogue Number: M00547540
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/01/2025
• 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
• Patient Sex: Unknown