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

Model Number	M00570380
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of inner shaft/sheath detachment of device or device component.Block h11: a wallflex biliary stent was received for analysis.Visual examination of the returned device found the inner sheath detached and the outer sheath found peeled.No other damages were noted to the delivery system.The reported event of stent failure to deploy was confirmed.The investigation concluded that the reported events and the additional observed damage were likely due to factors encountered during the procedure.It is possible that the lesion characteristics, handling of the device, the technique used by the physician, limited the performance of the device and contributed to the reported event and observed problems.Therefore, the most probable cause of the reported events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stents was implanted to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) stent placement procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the stent was attempted to be deployed, but the stent would not come off the sheath.Another wallflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the inner sheath was detached.Please see block h11 for full investigation details.

• 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: 21730574
• Report Number: 3005099803-2025-01308
• Device Sequence Number: 14502420
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: (01)08714729953197(17)261017(10)35085041
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 03/31/2025

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 Model Number: M00570380
• Device Catalogue Number: M00570380
• Device Lot Number: 0035085041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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