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

Model Number M00517710

Device Problem Difficult to Remove (1528)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an agile esophageal otw partially covered stent was to be implanted in the esophagus to treat an esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, the agile esophageal stent was deployed through a previously implanted non- boston scientific stent.During removal of the delivery system, the agile esophageal stent came off together with the delivery catheter.The procedure was completed with a 23mm x 10cm agile esophageal stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

• 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: 16277832
• MDR Text Key: 308551375
• Report Number: 3005099803-2023-00369
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 00191506006587
• UDI-Public: 00191506006587
• 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: 02/01/2023

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: 02/17/2024
• Device Model Number: M00517710
• Device Catalogue Number: 1771
• Device Lot Number: 0028889176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male