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); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1 (initial reported facility name) (b)(6) - reported here as it exceeded the maximum character limit of the designated field.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was to be implanted in the sigmoid colon to treat sigmoid stenosis during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2025.During the procedure, the stent was difficult to deploy and advance.It was noted that the stent failed to expand; hence, the stent was removed using snares.The procedure was completed with another stent of the same model.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 enteral stent was to be implanted in the sigmoid colon to treat sigmoid stenosis during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2025.During the procedure, the stent was difficult to deploy and advance.It was noted that the stent failed to expand; hence, the stent was removed using snares.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.Additional information received on january 21, 2026: it was later confirmed that a part of the stent was attached to the delivery system.
Additional Manufacturer Narrative
Block b5 (describe event or problem) and h6 (device codes) have been updated based on additional information received on january 21, 2026.Block e1 (initial reported facility name), (b)(6) hospital, reported here as it exceeded the maximum character limit of the designated field.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed imdrf impact code f2301 captures reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was to be implanted in the sigmoid colon to treat sigmoid stenosis during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2025.During the procedure, the stent was difficult to deploy and advance when the stent began to expand.The stent was removed partially deployed with the use of snares.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reported facility name) union hospital affiliated fujian medical university - reported here as it exceeded the maximum character limit of the designated field.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed imdrf impact code f2301 captures event of the additional device required to retrieve the device.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent partially deployed.The device was not returned for analysis; 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 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: the device was not returned for analysis; therefore, a technical analysis could not be performed.Labeling review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.Risk review: a risk review was completed and confirmed that the reported events of stent partially deployed and additional device required were defined in the risk documentation.These event types have 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 cause not established.

• 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: 24003826
• Report Number: 3005099803-2026-00116
• Device Sequence Number: 13361792
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)261018(10)35093942
• 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,Followup
• Report Date (Section B): 07/02/2026

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 Model Number: M00565060
• Device Catalogue Number: M00565060
• Device Lot Number: 0035093942
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 06/08/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/18/2026; 07/02/2026
• Date Device Manufactured: 10/18/2024
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 123 LB