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

Model Number	M00570370
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1006 captures the reportable event of small bowel perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered stent rmv was implanted during a stent placement procedure performed on an unknown date.On (b)(6) 2026, during a routine follow-up after stent placement, it was found that the stent had migrated and got stuck in the small bowel, causing a perforation.Surgery was performed, and the stent was explanted.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1006 captures the reportable event of small bowel perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent migration and perforation, bowel.The device has not been returned for product evaluation as it was disposed; therefore, a technical analysis could not be performed.However, stent migration and perforation, bowel are noted within the instructions for use (ifu) as possible adverse events associated with the use of the device.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the complaint device was not returned for evaluation as the device was disposed; therefore, a technical analysis could not be performed.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent migration and perforation are noted within the instructions for use (ifu) as possible adverse events associated with the use of the device.Risk review: a risk review was completed and confirmed that the events of stent migration, perforation, bowel and surgical intervention 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 known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered stent rmv was implanted during a stent placement procedure performed on an unknown date.On (b)(6) 2026, during a routine follow-up after stent placement, it was found that the stent had migrated and got stuck in the small bowel, causing a perforation.Surgery was performed, and the stent was explanted.No further information has been obtained despite good faith efforts.

• 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: 24735941
• Report Number: 3005099803-2026-01148
• Device Sequence Number: 18689915
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: M00570370
• Device Catalogue Number: M00570370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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