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

Model Number	M00514250
Medical Device Problem Codes	Break (1069); Human-Device Interface Problem (2949); Device Stenosis (4066)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 (b)(6) 2023, it was observed that the stent's distal end had overgrowth.The stent was moved slightly distally using rat tooth grasping forceps.During the procedure, it was also noted that the stent was obstructed by a small amount of food.The physician pushed past some impacted food and found that the stent had broken into two pieces.The patient was referred to a different hospital for stent removal and placement of a new stent.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a22 captures the reportable event of stent overgrowth.Imdrf device code a0106 captures the reportable event of stent obstruction.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f23 captures the reportable event of additional intervention performed to adjust the position of the stent.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: 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: 18501852
• Report Number: 3005099803-2023-06950
• Device Sequence Number: 15475890
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2025
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0031373096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown