MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? DUODENAL; STENT, METALLIC, EXPANDABLE, DUODENAL

Model Number	M00555870
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf patient code e2114 captures the reportable event of duodenal perforation.Imdrf impact code f08 captures the patient's hospital admission as a result of the adverse event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was implanted to treat a duodenal obstruction in the duodenal third portion during a duodenal stent procedure performed on (b)(6) 2025.On (b)(6) 2025, the patient was admitted to the emergency department, where a duodenal perforation was diagnosed.On (b)(6) 2025, the patient was informed of the complication.The exact cause and clinical details of the perforation remain undetermined.No additional adverse patient effects were reported.

• Brand Name: WALLFLEX? DUODENAL
• Common Device Name: STENT, METALLIC, EXPANDABLE, DUODENAL
• 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: 22719746
• Report Number: 3005099803-2025-03810
• Device Sequence Number: 15754813
• Product Code: MUM
• UDI-Device Identifier: 08714729902508
• UDI-Public: (01)08714729902508(17)260902(10)34758797
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K200257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2026
• Device Model Number: M00555870
• Device Catalogue Number: M00555870
• Device Lot Number: 0034758797
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 09/02/2024
• 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