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

Model Number	M00565110
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was to be implanted in the colon to treat malignant intestinal stenosis during a colonic stent implantation under digital subtraction angiography (dsa) procedure performed on (b)(6) 2025.During the procedure, the stent was kinked and could not move forward under force.The stent was not able to deploy because of this, and the procedure was cancelled.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of a cancelled/aborted procedure.
Additional Manufacturer Narrative
Blocks e1 (initial reporter's address) and g4 (premarket) have been corrected.Block h6: imdrf impact code f1001 captures the reportable event of a cancelled/aborted procedure.Block h11: a wallflex enteral colonic stent was received for analysis; however, the delivery system was not returned.Visual examination of the returned stent revealed no damage.Media inspection, based on photos provided by the customer, showed that the outer sheath was kinked.Product analysis could not confirm the reported events of stent failure to deploy and difficulty advancing the device, as these occurred during the procedure and could not be replicated in the laboratory setting.However, the reported event of a kinked sheath was confirmed through media inspection.There is insufficient evidence to determine whether the sheath kink was caused by physician manipulation during the procedure or by a device malfunction.Additionally, without the delivery system available for evaluation, the most probable cause of the event cannot be determined.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was to be implanted in the colon to treat malignant intestinal stenosis during a colonic stent implantation under digital subtraction angiography (dsa) procedure performed on (b)(6) 2025.During the procedure, the stent was kinked and could not move forward under force.The stent was not able to deploy because of this, and the procedure was cancelled there was 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22128062
• Report Number: 3005099803-2025-02449
• Device Sequence Number: 15624131
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: (01)08714729456582(17)261011(10)35044968
• 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 Model Number: M00565110
• Device Catalogue Number: M00565110
• Device Lot Number: 0035044968
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG