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

Model Number	4754
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Blood Protein Abnormal (4595)
Date of Event	04/23/2025
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 e0313 captures the reportable event of blood protein abnormal.Imdrf impact code f2301 captures the reportable event of additional device required to address stent migration.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stents was to be implanted during a procedure performed on (b)(6) 2025.On (b)(6) 2025 approximately two weeks, the stent migrated distally into duodenum.The patient then experienced abnormal lfts and/or blood counts.Another wallflex biliary stent was used to complete the procedure.The patient received a surgical intervention to remove the migrated stent.
Additional Manufacturer Narrative
Block b5 (event description) and block h6 (patient code and evaluation codes) have been corrected.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e0313 captures the reportable event of liver damage/dysfunction.Imdrf impact code f2301 captures the reportable event of additional device required to address stent migration.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stents was implanted to treat a malignant, procedure performed on (b)(6) 2025.During the post procedure, the stent migrated distally into duodenum and cause abnormal lfts and/or blood counts.An endoscopic procedure was performed to remove the migrated stent.Another wallflex biliary stent was used to complete the procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22047311
• Report Number: 3005099803-2025-02158
• Device Sequence Number: 8990466
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527(17)270319(10)36101351
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 4754
• Device Catalogue Number: 4754
• Device Lot Number: 0036101351
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/06/2025
• Date Device Manufactured: 03/19/2025
• 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