MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570700
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable impact code of additional device required to remove the migrated stent.Imdrf impact code f2202 captures the reportable impact code of the endoscopic procedure performed to address the stent migrated.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted in the duodenum and common bile duct (cbd) to treat a malignant obstruction during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2024.On (b)(6) 2025, it was found that the stent distally migrated out of the cbd into the stomach.This was noticed as the patient passageway became obstructed, but no specific symptoms were reported.The stent was retrieved and removed from the patient by performing an esophagogastroduodenoscopy combined with an ercp, and another wallflex biliary stent was implanted.The patient endure an endoscopic procedure to retrieve and implant a new stent.

• Brand Name: WALLFLEX? BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 22284901
• Report Number: 3005099803-2025-02687
• Device Sequence Number: 12994302
• Product Code: FGE
• UDI-Device Identifier: 08714729759294
• UDI-Public: (01)08714729759294(17)250718(10)32043945
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/18/2025

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 Expiration Date: 07/18/2025
• Device Model Number: M00570700
• Device Catalogue Number: M00570700
• Device Lot Number: 0032043945
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 07/19/2023
• 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