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

Model Number	M00565060
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted in the sigmoid colon to treat an intestinal obstruction due to sigmoid colon cancer during a stent placement procedure performed on (b)(6) 2025.During the procedure, the connection at the front section of the wallflex stent had become misaligned, and it was noted that the stent had burrs on the surface.The stent was removed partially deployed on the delivery system, and another of the same device was used to complete the procedure.There were no patient complications as a result of this event and the patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: a wallflex enteral stent with its delivery system was received for analysis.Visual examination of the returned device found the stent fully expanded and deployed.Additionally, the stainless steel was found bent, and the outer sheath kinked.No other problems were noted with the stent or the delivery system.Product analysis did not confirm the reported events of stent partially deployed and stent material deformation.The stent was returned fully expanded and deployed and in good condition.There is not enough evidence to determine whether the stent partially deployed allegation occurred as a result of physician manipulation of the device during the procedure or was related to a potential device malfunction.The investigation concluded that the additional observed events of stainless steel bent and outer sheath kinked were most likely caused due to procedural factors such as excess of force or the manner as the device was handled and manipulated.Therefore, a review and analysis of all available information indicate the most probable root cause of the reported events is unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted in the sigmoid colon to treat an intestinal obstruction due to sigmoid colon cancer during a stent placement procedure performed on (b)(6) 2025.During the procedure, the connection at the front section of the wallflex stent had become misaligned, and it was noted that the stent had burrs on the surface.The stent was removed partially deployed on the delivery system, and another of the same device was used to complete the procedure.There were no patient complications as a result of this event and the patient condition following the procedure was reported to be stable.

• 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: 24112037
• Report Number: 3005099803-2026-00236
• Device Sequence Number: 17506666
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)260103(10)33138655
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 01/03/2026
• Device Model Number: M00565060
• Device Catalogue Number: M00565060
• Device Lot Number: 0033138655
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 56 KG