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

Model Number M00517620

Device Problem Migration (4003)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that an agile esophageal fully covered rmv stent was implanted in the esophagus to treat a 3cm benign post-endoscopic submucosal dissection (esd) stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2023, the patient presented with pain during a scheduled stent removal procedure.The stricture has been resolved; however, it was noted that the stent could no longer be found.Subsequently, a computed tomography (ct) scan confirmed that the stent migrated in the descending colon.Eventually, the stent passed through the patient's stool and the procedure was completed.The patient is fine following the procedure.

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of agile esophageal stent migration.

• 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: 17401076
• MDR Text Key: 320205000
• Report Number: 3005099803-2023-04000
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K211960
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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
• Date Manufacturer Received: 07/07/2023
• 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