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

Model Number M00565050

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral colonic stent was to be implanted in the colo-hepatic region to treat a 5cm malignant intestinal obstruction due to adenocarcinoma during an intestinal stent implantation performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed smoothly inside the patient.The outer sheath was kinked, and the stent was partially deployed when it was removed from the patient.The procedure was completed with another wallflex enteral colonic stent.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of stent damaged.The wallflex enteral colonic stent and delivery system were received for analysis.Visual inspection revealed that the stent was fully expanded and deployed, the wires of the stent were loose in the middle, the outer sheath was kinked in two sections, and the inner sheath was kinked.Microscopical inspection confirmed that the wires were loose in the middle of the stent.A dimensional inspection of the outer diameter of the delivery system confirmed that it was within specification.No other issues were noted with the delivery system.Product analysis confirmed the reported device malfunction of sheath kinked; however, the reported device malfunction of a stent partially deployed was not confirmed as the stent returned fully expanded and deployed.The investigation concluded that the reported device malfunctions of outer sheath kinked, inner sheath kinked, and damaged stent were most likely due to procedural factors such as lesion characteristics, the handling of the device, or the technique used by the physician.Therefore, review and analysis of all 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 instructions for use (ifu)/product label.

• 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: 16775279
• MDR Text Key: 313636778
• Report Number: 3005099803-2023-02134
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0029811999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1