MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570370
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of stent incorrect size.Imdrf impact code f2301 captures the additional device used to remove the stent with an incorrect size from the patient.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) metal stent placement procedure performed on (b)(6) 2025.During the procedure, the physician believes that the metal stent is longer than the labeled length.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) metal stent placement procedure performed on (b)(6) 2025.During the procedure, the physician believes that the metal stent is longer than the labeled length.The procedure was completed with another of the same device.There was no patient complications were reported.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6 imdrf device code a0203 captures the reportable event of stent incorrect size.Imdrf impact code f2301 captures the additional device used to remove the stent with an incorrect size from the patient.Block h11: a wallflex biliary stents was received for analysis.Only the stent fully expanded and deployed was returned.Visual inspection did not identify failures or evidence that could be lost due to decontamination process.No other damages were noted to the stent.The reported event of stent size incorrect was not confirmed.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event and the observed failures.Therefore, the most probable root cause is no problem detected since the device complaint or problem cannot be confirmed.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• 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: 21946010
• Report Number: 3005099803-2025-01917
• Device Sequence Number: 8547934
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: (01)08714729953180(17)251211(10)33036479
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K240464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 12/11/2025
• Device Model Number: M00570370
• Device Catalogue Number: M00570370
• Device Lot Number: 0033036479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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