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

Model Number M00517400

Device Problems Premature Activation (1484); Material Deformation (2976); Positioning Problem (3009)

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

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

Block e1: the reported healthcare facility is: (b)(6) medical center.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a150103 captures the reportable event of stent prematurely deployed.Imdrf impact code f2303 captures the reportable event of administering steroids.

Event Description

It was reported to boston scientific corporation that an agile esophageal stent was to be implanted to treat an anastomatic stricture in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2023.During the procedure, the stent prematurely deployed before the distal handle was completely pulled back, which caused the stent to become deformed and migrate into the patient's stomach.The stent was removed, and the physician completed the procedure by administering steroids and using a cre balloon.The patient will be rescheduled for another stent placement procedure.There were no patient complications 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: 17744275
• MDR Text Key: 323384572
• Report Number: 3005099803-2023-04860
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973027
• UDI-Public: 08714729973027
• 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: Other
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00517400
• Device Catalogue Number: 1740
• Device Lot Number: 0031797586
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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
• Patient Outcome(s): Required Intervention