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 Code	Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Post procedure, on (b)(6) 2026, the patient came for a scheduled stent removal.Upon ercp it was found that there was tissue ingrowth on the distal flare of the stent.The physician had to pull scope out to remove the stent.The procedure was completed using an unspecified alternate method.There were no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent obstruction within device.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent obstruction within device.The device was not returned as the device was disposed; therefore, a technical analysis could not be performed.However, stent obstruction within device 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 the device was disposed; 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 obstruction within device 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.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Post procedure, on (b)(6) 2026, the patient came for a scheduled stent removal.Upon ercp it was found that there was tissue ingrowth on the distal flare of the stent.The physician had to pull scope out to remove the stent.The procedure was completed using an unspecified alternate method.There were no patient complications reported as a result of the procedure.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24490510
• Report Number: 3005099803-2026-00781
• Device Sequence Number: 10676708
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527(17)270714(10)36960828
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00547540
• Device Catalogue Number: M00547540
• Device Lot Number: 0036960828
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 07/14/2025
• 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