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

Model Number M00517440

Device Problem Migration (4003)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an agile esophageal fully covered stent was implanted in the esophagus just above the gastroesophageal junction to treat an ongoing leak from an esophageal fistula during an upper gastrointestinal endoscopy with stent placement procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2022, the stent was scheduled to be removed.During the stent removal procedure, it was noted that the stent had migrated.The stent was removed using alligator forceps and the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code (b)(6) captures the reportable event of stent migration.

Manufacturer Narrative

Block b5 has been updated with additional information received on february 26, 2024.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation that an agile esophageal fully covered stent was implanted in the esophagus just above the gastroesophageal junction to treat an ongoing leak from an esophageal fistula during an upper gastrointestinal endoscopy with stent placement procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2022, the stent was scheduled to be removed.During the stent removal procedure, it was noted that the stent had migrated.The stent was removed using alligator forceps and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on february 26, 2024.The stent was removed to evaluate the healing of the perforation that turned into fistula.

• 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: 18773028
• MDR Text Key: 336985287
• Report Number: 3005099803-2024-00584
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973065
• UDI-Public: 08714729973065
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2023
• Device Model Number: M00517440
• Device Catalogue Number: 1744
• Device Lot Number: 0027366827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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