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

Model Number	M00570360
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to april 01, 2025 as no specific event date was reported.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted for an unknown indication during a biliary stenting case performed on an unknown date.Prior to procedure, after opening the box and trying to remove the plastic piece from the tip of the stent, the stent started deploying, and the plastic piece was unable to be removed.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted for an unknown indication during a biliary stenting case performed on (b)(6) 2025.Prior to procedure, after opening the box and trying to remove the plastic piece from the tip of the stent, the stent started deploying, and the plastic piece was unable to be removed.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on may !4, 2025: it was reported that the event date and procedure date was on (b)(6) 2025.
Additional Manufacturer Narrative
Blocks b3, b5, has been updated with the additional information received on may 14, 2025.Block g2 was corrected to "company representative" and "health care professional" block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h11 a wallflex biliary stent and delivery system were returned for analysis.Visual inspection found the stent partially deployed.No other problems were noted to the stent or delivery system.Product analysis confirmed the reported event of stent premature deployment due to the condition in which the stent was returned.The investigation concluded that the reported event was most likely due to procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, the most probable root cause of the reported event is adverse event related to the procedure.

• 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: 22040824
• Report Number: 3005099803-2025-02159
• Device Sequence Number: 9061240
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: (01)08714729953173(17)260312(10)33615138
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 03/12/2026
• Device Model Number: M00570360
• Device Catalogue Number: M00570360
• Device Lot Number: 0033615138
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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