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

Model Number	M00565100
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block g4: premarket/510(k): k061877, k201159; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the colon to treat a stricture due to cancer during a colonoscopy procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, during deployment, the wires of the stent broke, and the stent lost its form.The stent was removed using forceps.The procedure was completed using a different stent.There was no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.A photo of the complaint device was provided, and the stent was noted to be deformed, and the wires were broken.
Additional Manufacturer Narrative
Blocks g4 (premarket/510(k) and h11 have been corrected.Block g4: premarket/510(k): k201159; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: a wallflex enteral stent was received for analysis; the delivery system was not returned.Visual inspection was performed, and the stent was found unraveled and deformed.Additionally, media inspection was performed on a photo provided by the complainant, and it was observed again that the stent was unraveled.No other damages were noted on the device.Product analysis confirmed the reported events of stent break and stent material deformation.The investigation concluded that the reported events were most likely due to procedural factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the reported events.Taking all available information into consideration, the most probable cause of the reported events is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with 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 implanted in the colon to treat a stricture due to cancer during a colonoscopy procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, during deployment, the wires of the stent broke, and the stent lost its form.The stent was removed using forceps.The procedure was completed using a different stent.There was no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.A photo of the complaint device was provided, and the stent was noted to be deformed, and the wires were broken.

• 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: 20965852
• Report Number: 3005099803-2024-06357
• Device Sequence Number: 12856768
• Product Code: MQR
• UDI-Device Identifier: 08714729456575
• UDI-Public: 08714729456575
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061877
• 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): 03/14/2025

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 Expiration Date: 07/30/2026
• Device Model Number: M00565100
• Device Catalogue Number: M00565100
• Device Lot Number: 0034534640
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown