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

Model Number M00513860

Device Problem Migration (4003)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1009 captures the reportable event of disturbed passage of solid food.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the stent.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal proximal release covered stent was implanted in the esophagus for the treatment of a 2cm stenosis due to esophageal cancer during a gastroscopy procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On september 7, 2023, the patient experienced disturbed passage of solid food and it was later noted that the stent migrated.On (b)(6) 2023, the stent was removed using biopsy forceps.On (b)(6) 2023, another ultraflex esophageal stent was implanted.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• 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: 18506871
• MDR Text Key: 332871945
• Report Number: 3005099803-2023-06951
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K091816
• 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: 01/12/2024

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: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 0030479806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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
• Patient Outcome(s): Required Intervention