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

Model Number	M00565060
Medical Device Problem Codes	Positioning Failure (1158); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6); reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the sigmoid colon to treat a malignant stenosis during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was severely tortuous.During the procedure, the stent did not expand properly and was removed using a snare.The procedure was completed using another of the same device.There was no patient complications reported due to this event and the patient condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the sigmoid colon to treat a malignant stenosis during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was severely tortuous.During the procedure, the stent did not expand properly and was removed using a snare.The procedure was completed using another of the same device.There was no patient complications reported due to this event and the patient condition following the procedure was reported to be stable.***additional information received on january 14, 2026*** it was reported that the stent did not deploy and was removed without using a snare.
Additional Manufacturer Narrative
Blocks b1, b2, b5, h1 and h6 (device codes) were updated with the additional information received on january 14, 2026.Block e1: initial reporter facility name: union hospital affiliated to fujian medical university; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.

• 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: 23996636
• Report Number: 3005099803-2026-00111
• Device Sequence Number: 18772592
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)260905(10)34782092
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Expiration Date: 09/05/2026
• Device Model Number: M00565060
• Device Catalogue Number: M00565060
• Device Lot Number: 0034782092
• 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: 01/14/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 09/05/2024
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 56 KG