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 Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
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.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event stent migration.Imdrf patient code e0506 captures the reportable event major hemorrhage.Imdrf impact code f2302 captures the reportable event of blood transfusion.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered stent was implanted in the common bile duct (cbd) to treat a post sphincterotomy bleeding during an endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy procedure performed on (b)(6) 2025.On (b)(6) 2025, the patient presented with low hemoglobin levels due to an internal bleeding.Upon endoscopic inspection, the wallflex stent was noted to be migrated out of the cbd into the small intestine, it was then removed using rat tooth forceps and replaced with a non-boston scientific device.According to the physician's assessment, the bleeding occurred as the stent migrated, and it was no longer applying pressure on the sphincterotomy implant zone.The patient was given blood transfusion and was expected to fully recover.Note: it was reported that the wallflex biliary rx fully covered stent system was implanted to treat a post sphincterotomy bleeding.However, per the wallflex biliary rx fully covered stent system directions for use (dfu), the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for treatment of benign biliary strictures.The device is not indicated for treatment of post sphincterotomy bleeding.
Additional Manufacturer Narrative
Block b5, g1 (manufacturer site address 1), h6 (impact codes) have been updated.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.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event stent migration.Imdrf patient code e0506 captures the reportable event major hemorrhage.Imdrf impact code f2302 captures the reportable event of blood transfusion.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f2203 captures the reportable event of imaging required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered stent was implanted in the common bile duct (cbd) to treat a post sphincterotomy bleeding during an endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy procedure performed on (b)(6) 2025.On (b)(6) 2025, the patient presented with low hemoglobin levels due to an internal bleeding.Upon fluoroscopic inspection, no evidence of stent migration into the duct was observed.However, the wallflex stent was noted to have migrated out of the cbd into the small intestine endoscopically, and it was then removed using rat tooth forceps and replaced with a non-boston scientific device.According to the physician's assessment, the bleeding occurred as the stent migrated, and it was no longer applying pressure on the sphincterotomy implant zone.The patient was given blood transfusion and was expected to fully recover.Note: it was reported that the wallflex biliary rx fully covered stent system was implanted to treat a post sphincterotomy bleeding.However, per the wallflex biliary rx fully covered stent system directions for use (dfu), the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for treatment of benign biliary strictures.The device is not indicated for treatment of post sphincterotomy bleeding.

• 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: 23230036
• Report Number: 3005099803-2025-05118
• Device Sequence Number: 9757914
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527
• 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
• 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): 10/28/2025

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: 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: 09/13/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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 Sex: Unknown