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

Model Number	M00565050
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf patient code a04 captures the reportable event of tip damaged/defective.
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 an 5cm intestinal obstruction secondary to sigmoid colon cancer during intestinal stent placement procedure performed on (b)(6), 2025.The patient anatomy was tortuous.During the procedure, the tip of the stent delivery system became kinked.As a result, the device could not cross the stenosis, and stent deployment could not be completed.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient condition at the of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block g2 (report source) has been corrected.Block h6: imdrf patient code a04 captures the reportable event of tip damaged/defective.Block h11: the wallflex enteral colonic stent and delivery system were received for analysis.The stent was returned fully covered and undeployed.Visual examination revealed that the stainless-steel shaft and the outer clear sheath were kinked.Functional testing could not be performed due to the kinks observed on the device.The tip of the delivery system was not damaged.No other issues were noted with the stent or the delivery system.Product analysis could not confirm the reported events of tip damage, partial stent deployment, or difficulty crossing the lesion with the delivery system.The observed kinks were most likely due to procedural factors such as lesion characteristics, device handling, and the technique used by the physician.These factors likely limited the device's performance and contributed to the delivery system's inability to cross the stenosis and the stent's failure to deploy.Therefore, a review and analysis of all available information indicate that the most probable cause is an adverse event related to procedure.
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 an 5cm intestinal obstruction secondary to sigmoid colon cancer during intestinal stent placement procedure performed on (b)(6) 2025.The patient anatomy was tortuous.During the procedure, the tip of the stent delivery system became kinked.As a result, the device could not cross the stenosis, and stent deployment could not be completed.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient condition at the of the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22011076
• Report Number: 3005099803-2025-02135
• Device Sequence Number: 5228715
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: (01)08714729456520(17)250906(10)32373533
• 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): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2025
• Device Model Number: M00565050
• Device Catalogue Number: M00565050
• Device Lot Number: 0032373533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG