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 Codes	Liver Damage/Dysfunction (1954); Insufficient Information (4580)
Date of Event	10/13/2025
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 a0106 captures the reportable event of stent obstruction within device.Imdrf patient code e1104 captures the reportable event of liver dysfunction.Imdrf patient code e2401 captures the reportable event of abnormal blood count.Imdrf impact code f08 captures the reportable event of patient was admitted to the hospital beyond the standard level of care.Imdrf impact code f2202 captures the reportable event of reintervention procedure was performed.Imdrf impact code f2301 captures the reportable event of stent was removed using rat tooth forceps.Imdrf impact code f0801 captures the reportable event of the patient was in the intensive care unit (icu) as of (b)(6) 2025.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary plus rx fully covered stent was implanted in the duodenum and common bile duct to treat a malignant pancreatic head mass during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.On (b)(6) 2025, during an emergent follow-up, the stent was believed to be occluded.The stent was removed using rat tooth forceps, and the physician confirmed that debris was present around the distal flange.Another wallflex stent was used to replace the occluded stent.The reintervention procedure resulted in abnormal liver function tests (lfts) and blood counts.The patient was in the intensive care unit (icu) as of (b)(6) 2025, and remained hospitalized beyond the standard level of care.

• 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: 23480501
• Report Number: 3005099803-2025-05822
• Device Sequence Number: 21389486
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 11/05/2025

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: 10/16/2025
• Initial Report FDA Received Date: 11/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown