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

Model Number M00517620

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Positioning Problem (3009)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

Event Description

It was reported to boston scientific corporation that an agile esophageal fully covered rmv stent was to be implanted to treat an anastomosis in the distal esophagus from a previous surgery during a gastroscopy with esophageal stent placement procedure performed on (b)(6), 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was fully deployed; however, the most distal part of the stent deployed inside the scope.The physician attempted to push the stent out of the scope using a foreign body forceps, but the stent was stuck and did not come out of the scope.The stent was removed together with the scope and a non-boston scientific device was used to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the stent was attempted to be implanted to treat an anastomosis in the distal esophagus from a previous surgery.However, per the agile esophageal fully covered rmv stent system instructions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, occlusion of concurrent esophageal fistulas and treating refractory benign esophageal strictures.The device is not indicated to be placed to treat anastomosis.

• 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: 18333980
• MDR Text Key: 330579360
• Report Number: 3005099803-2023-06586
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 12/15/2023

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 Model Number: M00517620
• Device Catalogue Number: 1762
• Device Lot Number: 0031281468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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