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

Model Number	M00565020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be used to treat a 5cm anatomic stricture in the duodenum caused by gastric and duodenum cancer during a gastroscopy with introduction of duodenal stent procedure performed on (b)(6) 2025.During the procedure, the stent broke into two parts.The broken stent remains implanted, and another stent was placed through it.Reportedly, the physician did not remove the stent due to bleeding and the anatomic stricture caused by the tumor.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
Additional Manufacturer Narrative
Block b1 (adverse event/product problem), b2 (outcomes attrib to adv event), h1 (type of reportable event) and h6 (patient codes and impact codes) have been corrected.Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code f2301 captures the event of an additional stent required that was placed through the broken stent.Block h11: investigation summary: based on the available information, boston scientific could not confirm the reported event of stent break.The device was not returned as it remains implanted; therefore, a technical analysis could not be performed.Without proper evaluation of the device, it is unknown if the reported event was due to the technique used during the procedure, anatomical conditions or related to device malfunction.Device history records review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the complaint device was not returned for evaluation as it remains implanted; therefore, a technical analysis could not be performed.The documentation provided includes pictures where it can be observed the device in the patient's anatomy.However, this is not enough evidence to confirm the reported events.Labeling review: a labeling review was performed and, from the information available, there is no information that the device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, hemorrhage, minor is noted within the ifu as a potential adverse event associated with the use of the device.Risk review: a risk review was completed and confirmed that the reported event of stent break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information, there is not enough evidence to confirm the reported event.Due to the lack of evidence and without proper evaluation of the complaint device, cause not established is selected as the most probable root cause.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be used to treat a 5cm anatomic stricture in the duodenum caused by gastric and duodenum cancer during a gastroscopy with introduction of duodenal stent procedure performed on (b)(6) 2025.During the procedure, the stent broke into two parts.The broken stent remains implanted, and another stent was placed through it.Reportedly, the physician did not remove the stent due to bleeding and the anatomic stricture caused by the tumor.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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 ; 9145716918
• MDR Report Key: 21775149
• Report Number: 3005099803-2025-01346
• Device Sequence Number: 10161967
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: (01)08714729456490(17)260620(10)34281087
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K201159
• 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): 04/21/2026

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: 06/20/2026
• Device Model Number: M00565020
• Device Catalogue Number: M00565020
• Device Lot Number: 0034281087
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 06/20/2024
• 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: Female
• Patient Weight: 50 KG