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

Model Number	M00565040
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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 enteral colonic stent was used to treat an approximately 2cm malignant colonic stricture during a colonoscopy performed on (b)(6) 2026.The patient's anatomy was reported to be tight due to the stricture but was not considered tortuous.During the procedure, an attempt was made to deploy the stent.Deployment had only reached approximately the mid-point, and the radiopaque (ro) marker had not yet reached the point of no return when the physician observed that the stent had already been fully deployed toward the splenic flexure.The stent remains implanted and another wallflex enteral colonic stent was used to complete the procedure.There was no patient complications reported as a result of this event, and the patient was noted to have fully recovered following the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used to treat an approximately 2cm malignant colonic stricture during a colonoscopy performed on (b)(6) 2026.The patient's anatomy was reported to be tight due to the stricture but was not considered tortuous.During the procedure, an attempt was made to deploy the stent.Deployment had only reached approximately the mid-point, and the radiopaque (ro) marker had not yet reached the point of no return when the physician observed that the stent had already been fully deployed toward the splenic flexure.The stent remains implanted and another wallflex enteral colonic stent was used to complete the procedure.There was no patient complications reported as a result of this event, and the patient was noted to have fully recovered following the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.However, stent positioning issue is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.The investigation concluded that the additional observed damage of outer sheath bent was most likely caused by factors encountered during the procedure, such as excessive force or the manner in which the device was handled and manipulated.Device history record: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: a wallflex enteral colonic delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer sheath bent.No other issues were noted to the delivery system.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, stent positioning issue is noted within the ifu as a possible adverse event associated with the use of the device.Risk review: a risk review was completed and confirmed that the reported event of stent positioning issue 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 a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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: 24317099
• Report Number: 3005099803-2026-00565
• Device Sequence Number: 11997432
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: (01)08714729456513(17)270324(10)36132779
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K061877
• 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): 04/13/2026

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: M00565040
• Device Catalogue Number: M00565040
• Device Lot Number: 0036132779
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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 Sex: Unknown