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

Model Number	M00565080
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: the initial reporter's address is (b)(6); reported here as the address exceeded character limit for designated field.Healthcare facility: (b)(6) hospital.Address: (b)(6).Block h6: imdrf device 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 used in the intestinal tract to treat a benign stenosis during an enterectomy with stent placement procedure performed on (b)(6) 2024.During preparation, it was noted that the stent tip was bent.The procedure was completed with another wallflex enteral stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex enteral stent was used to treat a benign intestinal stenosis.However, per the wallflex colonic stent system with anchor lock delivery system instructions for use (ifu), the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.The device is not indicated for the treatment of benign strictures.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: the initial reporter's address is (b)(6); reported here as the address exceeded character limit for designated field.Healthcare facility: (b)(6).Address: (b)(6) china.Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.Block h11: a wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found that the outer sheath was kinked, and the stainless-steel handle was bent.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of tip damaged/defective because no objective evidence was found during the product analysis.The additional investigation findings of the outer sheath kinked, and the stainless-steel handle bent were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).There is no indication on the reported event because no visible problem was noted on the tip.Therefore, taking all available information into consideration, the overall root cause of the reported event is no problem detected.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the stent was used to treat a benign intestinal stenosis.However, the ifu states, "the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.".
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be used in the intestinal tract to treat a benign stenosis during an enterectomy with stent placement procedure performed on (b)(6) 2024.During preparation, it was noted that the stent tip was bent.The procedure was completed with another wallflex enteral stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex enteral stent was used to treat a benign intestinal stenosis.However, per the wallflex colonic stent system with anchor lock delivery system instructions for use (ifu), the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.The device is not indicated for the treatment of benign strictures.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20903031
• Report Number: 3005099803-2024-06333
• Device Sequence Number: 9005623
• Product Code: MQR
• UDI-Device Identifier: 08714729456551
• UDI-Public: 08714729456551
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K234046
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 10/18/2025
• Device Model Number: M00565080
• Device Catalogue Number: M00565080
• Device Lot Number: 0032670337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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 Sex: Male