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

Model Number	M00570370
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2025-01721 and 3005099803-2025-01723 for the associated device information.It was reported to boston scientific corporation that two wallflex biliary rx fully covered rmv stents were to be implanted in the bile duct for the treatment of pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, it was observed under fluoroscopy that the stent was in the intrahepatic ducts, but a large portion of the stent was still in the duodenum.The physician stated that the stent was 'acting like a 10x80' stent; however, the stent was not measured during the procedure.A second wallflex biliary stent of the same size was used, but the same issue recurred.It is unknown how the stents were removed from the patient, and a different size stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.Block h11: a wallflex biliary stent and delivery system were received for analysis.Visual examination of the returned device found the stent fully covered by the outer sheath and undeployed.No damages were noted to the device.A functional inspection was performed; the stent was deployed by actuating the delivery system (slide the handle back along the stainless-steel tube).A dimensional inspection was performed, and the stent was measured to be within specification.Product analysis did not confirm the reported event of stent size incorrect as there is a lack of objective evidence to confirm the reported event; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2025-01721 and 3005099803-2025-01723 for the associated device information.It was reported to boston scientific corporation that two wallflex biliary rx fully covered rmv stents were to be implanted in the bile duct for the treatment of pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, it was observed under fluoroscopy that the stent was in the intrahepatic ducts, but a large portion of the stent was still in the duodenum.The physician stated that the stent was 'acting like a 10x80' stent; however, the stent was not measured during the procedure.A second wallflex biliary stent of the same size was used, but the same issue recurred.It is unknown how the stents were removed from the patient, and a different size stent was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 21862377
• Report Number: 3005099803-2025-01721
• Device Sequence Number: 20807812
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180(17)261111(10)35259059
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• 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): 07/17/2025

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: M00570370
• Device Catalogue Number: M00570370
• Device Lot Number: 0035259059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: Required Intervention
• Patient Sex: Unknown