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

Model Number	M00547540
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary plus rx fully covered stent had been implanted in the bile duct to treat a benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient anatomy was not tortuous at the time of stent placement.On (b)(6) 2026, the patient presented with elevated bilirubin levels.A subsequent ercp procedure revealed that the previously implanted stent had migrated out of the bile duct.The migrated stent was removed using rattooth forceps.A non-boston scientific stent was then placed to complete the procedure.No patient complications were reported as a result of this event.The patient condition was described as fully recovered at the conclusion of the procedure.
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 a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of rat tooth forceps to remove the migrated stent.Block h11: investigation results: boston scientific corporation could not confirm the reported event of stent migration.The device was not returned; therefore, product analysis could not be performed.The reported stent migration was known and documented in the labeling and documented in the labeling and all reasonable steps have been taken.Device history records review: a review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Labeling review: a product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, stent migration is noted within the instructions for use (ifu) as a known possible adverse event related to the use of the device.Risk review: a risk review was completed and confirmed that the event of "stent migration" and "additional device required" were 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 "known inherent risk of device".
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary plus rx fully covered stent had been implanted in the bile duct to treat a benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient anatomy was not tortuous at the time of stent placement.On (b)(6) 2026, the patient presented with elevated bilirubin levels.A subsequent ercp procedure revealed that the previously implanted stent had migrated out of the bile duct.The migrated stent was removed using rattooth forceps.A non boston scientific stent was then placed to complete the procedure.No patient complications were reported as a result of this event.The patient condition was described as fully recovered at the conclusion of the procedure.Note: according to the complainant, the stent placement was to treat a benign stricture.However, according to the the wallflex biliary plus rx fully covered stent system directions for use, the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code) were corrected following a medical review which identified that the stent was used for a benign stricture.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 a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of rat tooth forceps to remove the migrated stent.Block h11: investigation results: boston scientific corporation could not confirm the reported event of stent migration.The device was not returned; therefore, product analysis could not be performed.However, stent migration is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.Device history records review: a review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of "stent migration" and "additional device required" were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: a labeling review was performed and, from the information available, the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the stent was implanted to treat a benign stricture.The ifu states, "the wallflex biliary plus rx fully covered stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery." additionally, stent migration is noted within the ifu as a possible adverse event associated with the use of the device.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• 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: 24975198
• Report Number: 3005099803-2026-01499
• Device Sequence Number: 12009978
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 06/22/2026

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: M00547540
• Device Catalogue Number: M00547540
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown