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

Model Number	M00570360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent suture break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted to treat a stricture caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.The anatomy of the patient was not dilated prior to stent placement.During procedure, the stent was successfully deployed.After the stent was implanted, it was observed that the looped pull wire was detached.Due to this, the stent wire was exposed.The stent was then removed using a rescue combo rat tooth forceps and the procedure was completed using another of the same device.There was no patient complications reported as a result of the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to treat a stricture caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.The anatomy of the patient was not dilated prior to stent placement.During procedure, the stent was successfully deployed.After the stent was implanted, it was observed that the looped pull wire was detached.Due to this, the stent wire was exposed.The stent was then removed using a rescue combo rat tooth forceps and the procedure was completed using another of the same device.There was no patient complications reported as a result of the procedure.Additional information received on february 20, 2026 the stent was intended to be implanted in the common bile duct.The anatomy of the patient was not torturous.The stricture presented with a size of 2 cm.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent suture break.Block h11: investigation result: based on the available information, boston scientific could confirm the reported event of stent suture break.The device was not returned for analysis as it was disposed; therefore, a technical analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed the device with evidence of pull loop break.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.Media review: the device was not returned for analysis as it was disposed; therefore, a technical analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed the device with evidence of pull loop break.Device history record review (dhr): a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Risk review: a risk review of the wallflex biliary stents was completed and confirmed that the events of stent suture break and additional device required were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24324975
• Report Number: 3005099803-2026-00577
• Device Sequence Number: 13239780
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: (01)08714729953173(17)270716(10)36980744
• 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
• Device Explanted 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
• Report Date (Section B): 03/05/2026

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: M00570360
• Device Catalogue Number: M00570360
• Device Lot Number: 0036980744
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 07/16/2025
• 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 Age: 57 YR
• Patient Sex: Female