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

Model Number	M00565040
Medical Device Problem Codes	Positioning Problem (3009); 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 h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the dislodged stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted during a stent placement procedure performed on (b)(6) 2025.During the procedure, the stent did not fully expand and shifted from the targeted position.The procedure was completed by using a new 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 colonic stent was to be implanted in the colon during a colonoscopy procedure performed on december 11, 2025.The patient anatomy was tortuous (tight) prior to stent placement.During the procedure, the stent did not fully expand and shifted from the targeted position.Therefore, forceps were used to remove the unexpanded stent and 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 27, 2026: it was later confirmed that the indication for stent placement was due to a stricture.
Additional Manufacturer Narrative
Block b5 has been updated based on additional information received on january 27, 2026.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the dislodged stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted in the colon during a colonoscopy procedure performed on (b)(6) 2025.The patient anatomy was tortuous (tight) prior to stent placement.During the procedure, the stent did not fully expand and shifted from the targeted position.Therefore, forceps was used to removed the unexpanded stent and 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 b5 has been updated.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the dislodged stent.

• 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: 23982123
• Report Number: 3005099803-2026-00057
• Device Sequence Number: 16131730
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: (01)08714729456513(17)270523(10)36592196
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2026

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: M00565040
• Device Catalogue Number: M00565040
• Device Lot Number: 0036592196
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/27/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/20/2026; 02/18/2026
• Date Device Manufactured: 05/23/2025
• 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