MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex? Duodenal; stent,metallic,expandable,duodenal

Model Number	M00565020
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex duodenal stent was attempted to be implanted in the intestines during an intestinal stent implantation procedure performed on (b)(6) 2026.During the procedure when deployed, the stent fell off in advance, the deployment was not accurate, and the therapeutic effect could not be achieved.The procedure was completed using another of the same device.There were no patient complications reported as result of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25860690
• Report Number: 3005099803-2026-02912
• Device Sequence Number: 14744433
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: (01)08714729456490(17)261219(10)35521488
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00565020
• Device Catalogue Number: M00565020
• Device Lot Number: 0035521488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 12/19/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 158 LB