MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY PLUS RX STENT SYSTEM; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	M00547530
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h11: investigation results: boston scientific corporation could not confirm the reported event of stent premature deployment.The device was not returned; therefore, product analysis could not be performed.However, a media analysis was performed based on the photo provided by the complainant, and it was observed that the stent in a fully expanded/deployed state outside its package, with evidence that the shipping mandrel had been removed/pulled.However, it could not be determined whether the device was already fully deployed upon receipt or if deployment occurred afterward.The investigation findings do not lead to a clear conclusion about the cause of the reported event; therefore, the most probable cause was unable to be established.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event.Device technical analysis: the device was not returned; therefore, product analysis could not be performed.However, a media inspection of the photographs provided by the complainant show evidence that the stent was fully expanded and deployed outside its package.Additionally, there is evidence that the shipping mandrel was removed/pulled.Risk review: a risk review was completed and confirmed that the event of "stent premature deployment was defined in the risk documentation.This event type has 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 cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary plus rx fully covered stent was to be implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2026.During preparation, prior to the procedure, the stent was found already deployed upon opening the package.Another wallflex biliary plus rx fully covered stent was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX BILIARY PLUS RX STENT SYSTEM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 25263129
• Report Number: 3005099803-2026-02046
• Device Sequence Number: 15795249
• Product Code: FGE
• UDI-Device Identifier: 00191506044466
• UDI-Public: (01)00191506044466(17)280129(10)38466260
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• 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): 05/22/2026

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: M00547530
• Device Catalogue Number: M00547530
• Device Lot Number: 0038466260
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 01/29/2026
• 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