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

Model Number M00517460

Device Problems Break (1069); Positioning Failure (1158); Material Deformation (2976)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

Impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that an agile esophageal fully covered stent was used to treat an esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tight and was not dilated prior to stent placement procedure.During the procedure, when the stent was being deployed, it was noticed that the outer blue sheath was kinked.Subsequently, a snap was heard and the stent was unable to be fully deployed.The stent was reconstrained and was fully covered by the outer sheath when it was removed from the patient.The procedure was not completed due to device availability.There were no patient complications reported as a result of this event.

• 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: 16620454
• MDR Text Key: 312101952
• Report Number: 3005099803-2023-01609
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973089
• UDI-Public: 08714729973089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180144
• 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
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00517460
• Device Catalogue Number: 1746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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