MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	ESS-ESG-NXT
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 patient code e1022 is being used to capture the reportable event of esophageal perforation.Imdrf code f14 is being used to capture the reportable event of prolonged episode of care.Imdrf code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Imdrf code f2301 is being used to capture the reportable event of additional device required.Imdrf code f2203 is being used to capture the reportable event of imaging required.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.During the procedure, the overstitch nxt device could not be advanced into the esophagus.A diagnostic scope was then used, which revealed a perforation just below the upper esophageal sphincter (ues).The perforation was partially closed, and the original procedure was cancelled.The patient was admitted to the hospital for observation, and two ct scans were performed.The patient was discharged on (b)(6) 2025.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22480861
• Report Number: 3005099803-2025-03273
• Device Sequence Number: 12886418
• Product Code: OCW
• UDI-Device Identifier: 00811955020834
• UDI-Public: (01)00811955020834(11)241004(17)271004(10)AF06244
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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 Model Number: ESS-ESG-NXT
• Device Catalogue Number: ESS-ESG-NXT
• Device Lot Number: AF06244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/11/2025
• Date Device Manufactured: 10/04/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown