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

Model Number	M00570370
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Device Stenosis (4066)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	11/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h11: imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf patient code e050303 captures the reportable event of pulmonary embolism.Imdrf impact code f02 captures the reportable event of death.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted during a procedure performed on an unknown date.On (b)(6) 2025, the patient presented for stent removal.During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician tried to pull the stent out.However, there was tissue ingrowth through the distal wires of the stent.The stent would not move, and tissue damage would occur if the stent was forcibly removed.The physician decided to place another stent through the damaged stent (stent-on-stent fashion), which successfully completed the procedure.Following the successful placement, the patient passed away.It was noted that the patient death was not related to the product malfunction but from pulmonary embolism.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted in the common bile duct with portion out of the ampulla into the duodenum during a procedure performed on an unknown date.On (b)(6) 2025, the patient presented for a standard follow-up and a scheduled stent removal.During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician tried to pull the stent out.However, there was tissue ingrowth through the distal wires of the stent.The stent would not move, and tissue damage would occur if the stent was forcibly removed.The physician decided to place another stent of the same model through the damaged stent (stent-on-stent fashion), which successfully completed the procedure.Following the successful placement, the patient passed away.It was noted that the patient death was not related to the product malfunction but from pulmonary embolism.
Additional Manufacturer Narrative
Block b5 has been updated.Block h1 has been corrected.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h11: imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf patient code e050303 captures the reportable event of pulmonary embolism.Imdrf impact code f02 captures the reportable event of death.Imdrf impact code f2301 captures the reportable event of additional device required.

• 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 ; 9145716918
• MDR Report Key: 23783889
• Report Number: 3005099803-2025-06687
• Device Sequence Number: 5128785
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/15/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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; Death
• Patient Sex: Unknown