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

Model Number M00516700

Device Problem Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf patient code e2230 captures the reportable event of pan.Imdrf impact code f2301 captures the reportable event of the stent was removed using graspers.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent implanted in the esophagus to treat a stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2023.During the procedure, the stent was successfully deployed.On (b)(6) 2023, the patient was unable to eat and presented to the emergency room.Upper gi endoscopy was performed, and it was noted that the stent migrated into the stomach.The migration was due to stricture resolution; however, the patient was still experiencing pain and dysphagia.Subsequently, the stent was removed using graspers and the procedure was completed.

• Brand Name: WALLFLEX 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: 19130280
• MDR Text Key: 340448423
• Report Number: 3005099803-2024-01779
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0031071013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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
• Patient Outcome(s): Required Intervention