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

Model Number	M00565090
Medical Device Problem Code	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
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to the colon to treat a 5cm obstruction caused by cancer during an intestinal stenting via digital subtraction angiography (dsa) procedure performed on (b)(6) 2025.The anatomy of the patient was tortuous.During procedure, when the mark point of the stent was deployed halfway, the stent suddenly advanced into the body of the patient, specifically into the intestinal lumen, crossing the stenotic lesion.Reportedly, slight resistance was encountered during the deployment.Due to this event, the procedure was not completed.The stent was then removed using biopsy forceps via colonoscopy.On (b)(6) 2026, another wallflex stent was successfully implanted.There was no other patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6) reported here as the address exceeded character limit for the designated field.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Imdrf impact code f2301 captures the reportable event of the additional device required (forceps) to remove the 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: 24218363
• Report Number: 3005099803-2026-00362
• Device Sequence Number: 9366319
• Product Code: MQR
• UDI-Device Identifier: 08714729456568
• UDI-Public: (01)08714729456568(17)270814(10)37207046
• 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
• Report Date (Section B): 07/01/2026

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: M00565090
• Device Catalogue Number: M00565090
• Device Lot Number: 0037207046
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 07/01/2026
• Date Device Manufactured: 08/14/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 158 LB