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

Model Number	M00565050
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic enteral stent was to be implanted in the intestines to treat intestinal obstruction due to malignant tumors during an intestinal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous (tight) prior to stent placement.During the procedure, it was reported that the when the stent was deployed, it fell off prematurely, the deployment was not accurate, and the therapeutic effect could not be achieved.It was also that the advancer was stuck and the release was inaccurate.The stent was then removed using biopsy forceps.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 h6 has been updated.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic enteral stent was to be implanted in the intestines to treat intestinal obstruction due to malignant tumors during an intestinal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous (tight) prior to stent placement.During the procedure, it was reported that when the stent was deployed, it fell off prematurely, the deployment was not accurate, and the therapeutic effect could not be achieved.It was further reported that the advancer was stuck and the release was inaccurate.The stent was then removed using biopsy forceps.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.

• 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: 24117334
• Report Number: 3005099803-2026-00242
• Device Sequence Number: 18564402
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: (01)08714729456520(17)270103(10)35549970
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: M00565050
• Device Catalogue Number: M00565050
• Device Lot Number: 0035549970
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 01/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 59 KG