MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex Biliary; biliary stent system for benign strictures

Model Number	M00570370
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Pain (1994); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Restenosis (4576)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
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 patient code e2008 captures the reportable event of the implanted wallflex stent was not located during imaging.Imdrf patient code e233701 captures the reportable event of restenosis imdrf patient code e1104 captures the reportable event of liver damage/dysfunction imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2328 captures the reportable event of obstruction imdrf impact code f2202 captures the reportable event of a repeat ercp was performed.Imdrf impact code f2301 captures the reportable event of a new biliary metal stent was placed.Imdrf impact code f2203 captures the reportable event of no metal stent was located per imaging.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex rx fully covered biliary stent was implanted to treat a pancreatic head mass with stricture in the distal common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the wallflex stent was successfully placed with no complications.However, a few days post-stent placement, during an emergent follow-up, it was noted that the patient's liver function test results had suddenly increased, and the patient complained of pain.Imaging was performed, and no metal stent was located.In the physician's assessment, the stent had migrated distally.The patient then underwent a repeat ercp, and a new biliary metal stent was placed.

• 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 ; +1(914)571-6918
• MDR Report Key: 25627515
• Report Number: 3005099803-2026-02585
• Device Sequence Number: 18415434
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: M00570370
• Device Catalogue Number: M00570370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/28/2026
• 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