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

Model Number	M00570340
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Anemia (1706); Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pressure Sore/Ulcer (2326)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: imdrf patient code e201401 captures the reportable event of pressure ulcers.Imdrf patient code e0506 captures the reportable event of major hemorrhage.Imdrf patient code e2006 captures the reportable event of erosion.Imdrf patient code e0301 captures the reportable event of anemia.Imdrf impact code f2202 captures the reportable event of the patient underwent a repeat ercp.Imdrf impact code f2301 captures the reportable event of a resolution clip was placed.Imdrf impact code f08 captures the reportable event of patient was kept in the hospital after the index ercp.Imdrf impact code f23 captures the reportable event of bipolar cautery was used.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered stent rmv was implanted in the common bile duct to treat choledocholithiasis and for prophylaxis bleeding treatment during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2023.During the procedure, the wallflex biliary stent was successfully deployed.However, post stent placement, the patient started bleeding.On (b)(6) 2025, the patient underwent a repeat ercp, and the physician found the bleeding ulcer inside the distal duct wall.Bipolar cautery was applied, followed by the placement of a resolution clip and the administration of hemospray.In the physician's assessment, the pressure ulcer contributed to the bleeding, which was caused by the wallflex stent.The stent remains implanted, and the patient is currently admitted and under observation since the hemoglobin started to drop.In the physician's assessment, the hemoglobin level of the patient stabilized after the pressure ulcer was treated.On on (b)(6) 2025, the patient was discharged from the hospital.Note: according to the complainant, the wallflex biliary rx fully covered rmv stent was implanted for prophylaxis bleeding treatment and to treat common bile duct stones.However, per the wallflex biliary rx fully covered stent system rmv directions for use (dfu), the wallflex biliary rx fully covered stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22613829
• Report Number: 3005099803-2025-03575
• Device Sequence Number: 9564484
• Product Code: PNB
• UDI-Device Identifier: 08714729953159
• UDI-Public: (01)08714729953159(17)260503(10)33962591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2026
• Device Model Number: M00570340
• Device Catalogue Number: M00570340
• Device Lot Number: 0033962591
• 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: 07/01/2025
• Initial Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 05/03/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown