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

Model Number	M00555780
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be used to treat a stenosis in the lower colon during a colonoscopy with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was impossible to deploy.It was noted that the guide catheter was folded.The stent was removed, and the procedure was not completed.No patient complication was reported due to this event.
Additional Manufacturer Narrative
Block g2: report source: materiovigilance incident # (b)(4).Block h6: imdrf impact code f1001 captures the reportable event of canceled procedure post sedation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be used to treat a stenosis in the lower colon during a colonoscopy with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was impossible to deploy, and it was noted that the guide catheter was folded.The stent was removed, and the procedure was not completed.No patient complication was reported due to this event.
Additional Manufacturer Narrative
Block a3b: gender has been updated.Block b5 has been updated.Block g2: report source: materiovigilance incident # (b)(4).Block h6: imdrf impact code f1001 captures the reportable event of canceled procedure post sedation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be used to treat a stenosis in the lower colon during a colonoscopy with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was impossible to deploy.It was noted that the guide catheter was folded.The stent was removed, and the procedure was not completed.No patient complication was reported due to this event.Additional information received on january 8, 2025: it was reported that the inner yellow sheath was kinked, preventing the stent from being released.Additional information received on january 22, 2025.It was reported that the stent was implanted to treat a colon cancer.
Additional Manufacturer Narrative
Block b5 has been corrected.The additional information received on january 8, 2025, and january 22, 2025, have been included.Block g2: report source: materiovigilance incident # (b)(4).Block h6: imdrf impact code f1001 captures the reportable event of canceled procedure post sedation.
Additional Manufacturer Narrative
Block b5 has been corrected.Block g2: report source: materiovigilance incident # (b)(4).Block h6: imdrf impact code f1001 captures the reportable event of canceled procedure post sedation.Block h11: the wallflex enteral stent and delivery system was returned for analysis.Visual inspection found the stent fully covered and undeployed.In addition, the stainless-steel shaft was returned detached and kinked, and the inner sheath was returned kinked.Product analysis confirmed the reported events of stent failure to deploy and inner shaft kinked.The investigation concluded that these events and the additional observed damage of stainless-steel shaft detached and kinked were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician, which could have resulted in these damages noted in the device.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be used to treat a stenosis in the lower colon during a colonic stenting for colon cancer with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was impossible to deploy.Additionally.It was noted that the inner yellow sheath was kinked, which prevented the stent from being released.As a result, the stent was removed, and the procedure was not completed.No patient complication was reported due to 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: 21026420
• Report Number: 3005099803-2024-06693
• Device Sequence Number: 18387020
• Product Code: MQR
• UDI-Device Identifier: 08714729902607
• UDI-Public: 08714729902607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200257
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 08/20/2026
• Device Model Number: M00555780
• Device Catalogue Number: M00555780
• Device Lot Number: 0034672363
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 02/06/2025; 02/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/03/2025; 02/06/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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 Sex: Unknown