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

Model Number M00517770

Device Problem Difficult to Remove (1528)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that an agile esophageal otw fully covered stent was to be implanted to treat a malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement procedure.During the procedure, the stent was successfully placed; however, when the delivery system was removed, the stent became caught on the delivery system.Subsequently, the stent and the guidewire were removed from the patient along with the delivery system.The procedure was completed with another agile esophageal stent.There were no patient complications reported as a result of this event.

• Brand Name: AGILE ESOPHAGEAL OTW
• 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: 16932142
• MDR Text Key: 315914917
• Report Number: 3005099803-2023-02616
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 00191506006648
• UDI-Public: 00191506006648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211960
• 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: 05/15/2023

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 Expiration Date: 05/25/2024
• Device Model Number: M00517770
• Device Catalogue Number: 1777
• Device Lot Number: 0029477936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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