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

Model Number M00517250

Device Problem Activation Failure (3270)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a150101 captures the reportable event of a stent's failure to expand.

Event Description

It was reported to boston scientific corporation that an agile esophageal partially covered stent was to be implanted in the esophagus during a procedure performed on an unknown date.During the procedure, the stent was deployed inside the patient but could not expand completely.The procedure was completed with another agile esophageal stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 19056186
• MDR Text Key: 340448540
• Report Number: 3005099803-2024-01409
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729972952
• UDI-Public: 08714729972952
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/05/2024

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
• Device Operator: Health Professional
• Device Model Number: M00517250
• Device Catalogue Number: 1725
• Device Lot Number: 0031927728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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