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

Model Number	M00570370
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.During procedure, post deployment the stent's retrieval loop was deformed.The patient is scheduled for a follow up spyglass procedure in a few weeks.The physician is comfortable leaving the stent inside the patient and is planning to swap the stent for a new one.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.During procedure, post deployment the stent's retrieval loop was deformed.The patient is scheduled for a follow up spyglass procedure in a few weeks.The physician is comfortable leaving the stent inside the patient and is planning to swap the stent for a new one.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: the wallflex billiary stent was not returned for evaluation.Therefore, product analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed that the stent was deformed.Media analysis confirmed the reported event of stent material deformation.However, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.There is not enough evidence to determine if the reported event was related to the physician's technique during the procedure, due to the anatomical conditions or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.During procedure, post deployment the stent's retrieval loop was deformed.The patient is scheduled for a follow up spyglass procedure in a few weeks.The physician is comfortable leaving the stent inside the patient and is planning to swap the stent for a new one.There was no patient complications reported as a result of this event.Additional information received on april 09, 2025, and april 24, 2025.The stent was removed without any problems.The removed stent was then disposed.The information regarding when the stent was removed was not available per customer.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: the wallflex billiary stent was not returned for evaluation.Therefore, product analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed that the stent was deformed.Media analysis confirmed the reported event of stent material deformation.However, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.There is not enough evidence to determine if the reported event was related to the physician's technique during the procedure, due to the anatomical conditions or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.Block b5 has been updated with the additional information received on april 09, 2025, and april 24, 2025.

• 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: 21702135
• Report Number: 3005099803-2025-01194
• Device Sequence Number: 20800419
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180(17)260819(10)34660594
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• 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,Followup,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2026
• Device Model Number: M00570370
• Device Catalogue Number: M00570370
• Device Lot Number: 0034660594
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/15/2025; 04/09/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/09/2025; 05/06/2025
• Date Device Manufactured: 08/19/2024
• 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
• Patient Sex: Unknown