MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGILE ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00517650

Device Problems Break (1069); Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an agile esophageal fully covered rmv stent was used in the esophagus to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, after several attempts to deploy the stent, the handle was detached.The stent was fully covered by the outer sheath when it was removed from the patient; however, the physician attempted to deploy the stent outside the patient.The procedure was completed with another agile esophageal stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent was partially deployed.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the investigation findings of stent partially deployed.Block h10: an agile esophageal fully covered rmv stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the outer sheath detached from the hub.The outer clear sheath was kinked while the outer blue sheath was buckled and also kinked.Functional inspection could not be performed due to the sheath being detached from the hub.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy because the stent was received partially deployed.In addition, the reported event of handle break was also confirmed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) could have contributed on the observed events of sheath kinked and buckled which resulted to the stent being unable to fully 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.

• Brand Name: AGILE ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 18284937
• MDR Text Key: 330120344
• Report Number: 3005099803-2023-06498
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K180144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00517650
• Device Catalogue Number: 1765
• Device Lot Number: 0031626732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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