MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex Biliary PLUS RX Stent System; Stents, Drains And Dilators For The Biliary Ducts

Model Number	M00547520
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wall flex biliary plus rx fully covered stent was implanted in the stomach to treat a malignancy during an eus-guided hepatic gastrostomy (eus-hgs) procedure performed on (b)(6) 2026.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent was successfully implanted.However, during a follow-up evaluation on (b)(6) 2026, a computed tomography (ct) scan revealed that the wall flex biliary stent had migrated into the stomach.A laparoscopic procedure was subsequently performed, and the stent was successfully explanted.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2203 captures the reportable event of computed tomograpy (ct) scan was performed.Imdrf impact code f2202 captures the reportable event of laparoscopy was performed.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50334646
• Report Number: 3005099803-2026-03416
• Device Sequence Number: 14820159
• Product Code: FGE
• UDI-Device Identifier: 00191506044510
• UDI-Public: (01)00191506044510
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Model Number: M00547520
• Device Catalogue Number: M00547520
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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