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

Model Number	M00565050
Medical Device Problem Codes	Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a colonic obstruction during a colonoscopy procedure performed on (b)(6) 2025.The patient's anatomy was tight or tortuous prior to stent placement.During the procedure, the stent failed to expand inside the patient.The stent was unable to be retrieved safely.Therefore, the physician left the stent in place as it posed less risk to the patient than to remove it.The procedure was then completed by implanting another stent of the same model.There were no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event stent failure to expand.Imdrf device code a150207 captures the reportable event stent difficult to remove.Imdrf patient code e2008 captures the reportable event unretrieved device fragments.Imdrf impact code f2301 captures the reportable event additional device required.

• 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: 23666188
• Report Number: 3005099803-2025-06253
• Device Sequence Number: 18354287
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: (01)08714729456520(17)261205(10)35424206
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 11/27/2025

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: M00565050
• Device Catalogue Number: M00565050
• Device Lot Number: 0035424206
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/27/2025
• Date Device Manufactured: 12/05/2024
• 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 Sex: Unknown