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

Model Number	M00565060
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a 9cm malignant colonic tumor during an endoscopic colon stenting procedure performed on (b)(6) 2025.During procedure, the stent was managed to be fully deployed.However, it was noticed that there were ruptured zones in the stent, and since the stent had already been deployed, it could no longer be retrieved.The procedure was completed with this stent the patient was left with the damaged stent inside.Future observations are required since it is possible that the patient might have a perforation or bleeding due to the stent rupture zones.The patient's condition was stable at the end of the procedure, and there were no complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 has been updated based on the additional information provided on october 21, 2025.Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a 9cm malignant colonic tumor during an endoscopic colon stenting procedure performed on (b)(6) 2025.During procedure, the stent was managed to be fully deployed.However, it was noticed that there were ruptured zones in the stent, and since the stent had already been deployed, it could no longer be retrieved.The procedure was completed with this stent the patient was left with the damaged stent inside.Future observations are required since it is possible that the patient might have a perforation or bleeding due to the stent rupture zones.The patient's condition was stable at the end of the procedure, and there were no complications reported as a result of this event.Additional information received on october 21, 2025: it was later confirmed that the patient's anatomy was tortuous and deformed.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a 9cm malignant colonic tumor during an endoscopic colon stenting procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and deformed.During procedure, the stent was managed to be fully deployed.However, it was noticed that there were ruptured zones in the stent, and since the stent had already been deployed, it could no longer be retrieved.The procedure was completed with this stent the patient was left with the damaged stent inside.Future observations are required since it is possible that the patient might have a perforation or bleeding due to the stent rupture zones.The patient's condition was stable at the end of the procedure, and there were no complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: only the handle of the delivery system was returned for analysis, the wallflex stent was not returned.Visual inspection of the device found the inner sheath and the outer sheath kinked.Additionally, media analysis was performed on a photograph provided by the complainant where it can be observed that the stent wires were broken.Product investigation confirmed the reported event of stent break based on media analysis.However, there is not enough evidence to determine whether this event was due to the physician's manipulation during the procedure or related to a device malfunction.Additionally, the investigation concluded that additional observed events of inner sheath and outer sheath kinked were most likely caused by procedural factors, including the application of excessive force and/or improper handling and manipulation of the device during use.Based on all available information, the investigation selected the most probable root cause of cause not established.

• 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: 23344150
• Report Number: 3005099803-2025-05364
• Device Sequence Number: 18504703
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)261018(10)35093942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/12/2026

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: M00565060
• Device Catalogue Number: M00565060
• Device Lot Number: 0035093942
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 12/18/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/12/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 60 KG