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

Model Number	H965431100
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to the common bile duct to treat an obstructive jaundice caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, the operator monitored the alignment of the proximal and distal radiopaque markers under fluoroscopic guidance.Mild resistance was encountered during deployment, prompting repositioning and wire manipulation to ensure proper alignment of the markers.Deployment was initiated under combined fluoroscopic and endoscopic visualization.Unexpectedly, an early release of tension despite maintaining correct marker positioning and continuous fluoroscopic observation.Upon assessment, the stent was found to be fully deployed within the common bile duct (cbd), appearing short and proximally migrated, resulting in failure to achieve adequate biliary drainage.The likely contributing factors include excessive stent radial force, possible pre-loading under tension, or a defect in the delivery system.The stent was then removed from the patient.The procedure was completed using another of the same device.There were no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: the wallflex billiary stent was not returned for evaluation.Therefore, product analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed the device in the patient's anatomy.Media analysis could not confirm the reported event of stent positioning issue.There was no evidence shown on the documentation to confirm the event of stent positioning issue.As the device was not returned, there is not enough evidence to determine whether the stent positioning issue was due to the physician's device manipulation during the procedure or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to the common bile duct to treat an obstructive jaundice caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, the operator monitored the alignment of the proximal and distal radiopaque markers under fluoroscopic guidance.Mild resistance was encountered during deployment, prompting repositioning and wire manipulation to ensure proper alignment of the markers.Deployment was initiated under combined fluoroscopic and endoscopic visualization.Unexpectedly, an early release of tension despite maintaining correct marker positioning and continuous fluoroscopic observation.Upon assessment, the stent was found to be fully deployed within the common bile duct (cbd), appearing short and proximally migrated, resulting in failure to achieve adequate biliary drainage.The likely contributing factors include excessive stent radial force, possible pre-loading under tension, or a defect in the delivery system.The stent was then removed from the patient.The procedure was completed using another of the same device.There were no patient complications reported as a result of the procedure.

• Brand Name: WALLSTENT 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23924845
• Report Number: 3005099803-2025-06932
• Device Sequence Number: 9012814
• Product Code: FGE
• UDI-Device Identifier: 08714729317937
• UDI-Public: (01)08714729317937(17)251128(10)32946902
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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 Expiration Date: 11/28/2025
• Device Model Number: H965431100
• Device Catalogue Number: H965431100
• Device Lot Number: 0032946902
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/21/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/15/2026
• Date Device Manufactured: 11/29/2023
• 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: Male