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

Model Number	ESS-ESG-NXT
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 device code a150205 is being used to capture the reportable event of device difficult to advance.Imdrf code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a stent suturing procedure on (b)(6) 2025.During insertion, the overstitch device could not be advanced into the patient's esophagus.The physician attempted a jaw thrust and applied extra lube to the device but was still unsuccessful.Then, the physician attempted to use an overtube device and saw a perforation in the patient's esophagus believed to be caused by the overstitch nxt and aborted the procedure.The patient was admitted to the icu.After 3 nights in the hospital, the patient was discharged.
Additional Manufacturer Narrative
Block h6: device code a150205 is being used to capture the reportable event of device difficult to advance.Imdrf code f1001 is being used to capture the reportable event of absence of treatment.Correction: block b1 and b2 updated.Block h11: the returned overstitch device was analyzed.A visual inspection was performed.The device was returned without the anchor exchange.It was observed the device was without the two endcap tape hooks and one sheath tape detachment.The reported event of device difficult to advance could not be confirmed.Based on the information available there is not enough evidence to determine whether the device difficult to advance was due to the physician's technique during the procedure, tortuous condition of patient, or was related to a device malfunction.Regarding the events of cancelled/rescheduled post sedation/sedation unknown, additional device required, and intensive care, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.In accordance with the information provided, the event perforation, is a potential adverse event associated with the use of the device.This adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).It was also observed the device was without the two endcap tape hooks and one sheath tape detachment.These conditions happened during the procedure, for this reason these are cataloged as adverse events of procedure.All compiled information on this investigation determines that the most probable cause is "cause not established".The conclusion is acceptable because of the analysis of the available information in the complaint and objective evidence did not determine a more specific complaint cause.There is no evidence the device was improperly used per the instructions for use (ifu), and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used during a stent suturing procedure on (b)(6) 2025.During insertion, the overstitch device could not be advanced into the patient's esophagus.The physician attempted a jaw thrust and applied extra lube to the device but was still unsuccessful.Then, the physician attempted to use an overtube device and saw a perforation in the patient's esophagus believed to be caused by the overstitch nxt and aborted the procedure.The patient was admitted to the icu.After 3 nights in the hospital, the patient was discharged.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22872867
• Report Number: 3005099803-2025-04065
• Device Sequence Number: 5689743
• Product Code: OCW
• UDI-Device Identifier: 00811955020834
• UDI-Public: (01)00811955020834
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other; Hospitalization
• Patient Sex: Unknown