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

Model Number	M00570370
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Imdrf device code a0501 captures the reportable event of inner sheath/shaft detachment of device or device component.Imdrf impact code f2301 captures the reportable event of the detached inner catheter being removed from the patient using another device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered stent rmv was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent was very difficult to deploy but was eventually deployed when the handle was fully retracted.During removal of the catheter, it was noted that the inner catheter broke.The detached catheter was removed from the patient, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of inner sheath/shaft detachment of device or device component.Imdrf impact code f2301 captures the reportable event of the detached inner catheter being removed from the patient using another device.Block h11: a wallflex biliary stent was received for analysis.Visual examination of the returned device found the inner sheath detached and kinked.No other damages were noted to the delivery system.The reported event of inner shaft/sheath detachment of device or device component was confirmed as the device was returned without the inner sheath.However, the reported event of stent failure to deploy could not be confirmed as this event occurred during the procedure and it is not possible to replicate in the laboratory of analysis.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 (force applied), 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 fully covered stent rmv was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent was very difficult to deploy but was eventually deployed when the handle was fully retracted.During removal of the catheter, it was noted that the inner catheter broke.The detached catheter was removed from the patient, and the procedure was completed.There were no patient complications reported 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20801247
• Report Number: 3005099803-2024-06031
• Device Sequence Number: 7895030
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: 08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/08/2025

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
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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