MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565110
Medical Device Problem Codes	Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enternal stent was to be implanted in the colon to treat a malignant tumor (30mmx20mm moderate to severe stenosis) during an endoscopic intestinal stenting procedure performed on (b)(6) 2026.The patient's anatomy was moderate to severely stenosed.During the procedure, it was reported that the implanter was stuck during deployment, and the stent was pushed to the far end.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enternal stent was to be implanted in the colon to treat a 30mmx20mm malignant tumor during an endoscopic intestinal stenting procedure performed on (b)(6) 2026.The patient's anatomy has moderate to severe stenosis.During the procedure, it was reported that the implanter was stuck during deployment, and the stent was pushed to the far end.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 (describe event or problem) has been updated.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: a wallflex enteral stent did not return for analysis.However, a media inspection of the video provided by the complainant noted that there is evidence of difficulty advancing into the scope.No other damages were noted to the stent or the delivery system based on the available documentation.Product analysis confirmed the reported event of delivery system difficult to cross lesion.However, there is not enough evidence to determine whether this event was due to the physician's technique during the procedure or related to a device malfunction.The reported event of stent position issue could not be confirmed during device analysis.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, stent positioning issue is noted within the ifu as a potential adverse event associated with the use of the device.Taking all available information into consideration, the selected most probable cause is known inherent risk of device.

• Brand Name: WALLFLEX? COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 24190326
• Report Number: 3005099803-2026-00316
• Device Sequence Number: 9649559
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: (01)08714729456582(17)260820(10)34673614
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 Expiration Date: 08/20/2026
• Device Model Number: M00565110
• Device Catalogue Number: M00565110
• Device Lot Number: 0034673614
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 79 KG