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

Model Number	M00565040
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of cancelled or rescheduled procedure.
Event or Problem Description
Note: this report pertains to one of the four devices used on the same patient.Refer to manufacturer report# 3005099803-2023-03080, 3005099803-2023-03081, 3005099803-2023-03082, and for the associated device information.It was reported to boston scientific corporation on may 24, 2023, that a wallflex enteral colonic stent was to be implanted in the sigmoid colon to treat a 6 cm malignant colonic obstruction during a colonoscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the first wallflex colonic stent (the subject of mfr.Report # 3005099803-2023-03080) did not deploy, the handle broke, and the stainless-steel shaft was kinked.A second wallflex colonic stent (the subject of mfr.Report # 3005099803-2023-03081) was used, but similar issue was encountered.The stent did not deploy, the handle broke, and the stainless-steel shaft kinked.A third wallflex colonic stent (the subject of mfr.Report # 3005099803-2023-03082) was used, but the stent did not deploy, and the stainless-steel shaft was kinked.A fourth wallflex colonic stent (the subject of this report) was used, but still the stent did not deploy, and the stainless-steel shaft kinked.Consequently, the procedure was not completed, and no secondary procedure was scheduled.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of cancelled or rescheduled procedure.Block h10: the wallflex enteral colonic stent and delivery system were received for analysis.Visual inspection of the returned device found the stent was fully covered and undeployed.The stainless-steel handle was slightly bent.The outer blue sheath was detached from the hub handle and stretched in the hub section, while the outer clear sheath was slightly pushed out of the tip and buckled in different sections.Functional inspection was not performed due to the outer sheath's detachment from the hub handle.No other damages were noted on the stent or delivery system.Product analysis confirmed the reported events of stent failure to deploy and stainless-steel shaft kinking.The investigation concluded that the reported events and the additional findings of handle detachment or separation, sheath buckle or accordion, and sheath stretching were most likely due to procedural factors encountered during procedure.It may be that lesion characteristics, handling of the device, and the technique used by the physician (amount of force applied), limit the performance of the device and could have resulted in the damages noted on the device and the stent's inability to deploy during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause 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
Note: this report pertains to one of the four devices used on the same patient.Refer to manufacturer report# 3005099803-2023-03080, 3005099803-2023-03081, 3005099803-2023-03082, and 3005099803-2023-03083 for the associated device information.It was reported to boston scientific corporation on may 24, 2023, that a wallflex enteral colonic stent was to be implanted in the sigmoid colon to treat a 6 cm malignant colonic obstruction during a colonoscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the first wallflex colonic stent (the subject of mfr.Report # 3005099803-2023-03080) did not deploy, the handle broke, and the stainless-steel shaft was kinked.A second wallflex colonic stent (the subject of mfr.Report # 3005099803-2023-03081) was used, but similar issue was encountered.The stent did not deploy, the handle broke, and the stainless-steel shaft kinked.A third wallflex colonic stent (the subject of mfr.Report # 3005099803-2023-03082) was used, but the stent did not deploy, and the stainless-steel shaft was kinked.A fourth wallflex colonic stent (the subject of this report) was used, but still the stent did not deploy, and the stainless-steel shaft kinked.Consequently, the procedure was not completed, and no secondary procedure was scheduled.There were no reported patient complications 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17098473
• Report Number: 3005099803-2023-03083
• Device Sequence Number: 12678326
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 09/14/2023
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0028014744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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: Female