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

Model Number M00565050

Device Problems Break (1069); Positioning Failure (1158); Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on august 18, 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture in the sigmoid colon during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, a scope was initially placed then the guidewire was put through and was advanced to the obstruction.The wallflex enteral colonic stent was put over the wire and pushed through the obstruction along with the scope.The physician then removed the scope and attempted to deploy the stent with 100% fluoroscopy.During stent deployment, resistance was met and a "pop" was felt at the handle and the handle was noted to be broken.Subsequently, the wallflex enteral colonic stent was unable to be deployed and was removed from the patient.Post procedure, the patient abdomen looked distended.Colonoscopy was performed and perforation was noted above the stricture.Surgery was done on the same day to close the perforation.The patient was fully recovered at the end of the procedure.Note: in the physician's assessment there was no relationship between the stent failure to deploy, handle break and the perforation.In the physician's assessment, perforation was likely related poor visualization of the stricture; as the wallflex stent was advanced to the stricture over the wire without endoscope visualization.

Manufacturer Narrative

Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the surgical intervention performed to treat patient's perforation.Block h10: a wallflex enteral colonic stent and delivery system were returned for analysis.The stent was received not deployed.Visual examination of the returned device found the outer blue sheath detached from the handle and was bent.The outer clear sheath was also kinked.No other problems were noted to the stent and delivery system.The reported events of stent failure to deploy and handle break were confirmed.The reported events and the observed failures were most likely due to factors encountered during the procedure.It may be that handling and excessive manipulation of the device without enough care, could result to handle break, outer sheath kink and deployment failure.Forcing the device against significant resistance could result in device damage or loss of functionality.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, perforation is noted within the dfu as a known possible adverse event related to the use of the device.Block h11: (device codes) has been corrected.

Event Description

It was reported to boston scientific corporation on august 18, 2022, that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture in the sigmoid colon during a colonoscopy procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous.During the procedure, a scope was initially placed then the guidewire was put through and was advanced to the obstruction.The wallflex enteral colonic stent was put over the wire and pushed through the obstruction along with the scope.The physician then removed the scope and attempted to deploy the stent with 100% fluoroscopy.During stent deployment, resistance was met, and a "pop" was felt at the handle and the handle was noted to be broken.Subsequently, the wallflex enteral colonic stent was unable to be deployed and was removed from the patient.Post procedure, the patient abdomen looked distended.Colonoscopy was performed and perforation was noted above the stricture.Surgery was done on the same day to close the perforation.The patient was fully recovered at the end of the procedure.Note: in the physician's assessment there was no relationship between the stent failure to deploy, handle break and the perforation.In the physician's assessment, perforation was likely related poor visualization of the stricture as the wallflex stent was advanced to the stricture over the wire without endoscope visualization.

• Brand Name: WALLFLEX COLONIC
• Type of Device: 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: 15433037
• MDR Text Key: 300031884
• Report Number: 3005099803-2022-05145
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0027943829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention