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

Model Number	ESS-G02-NXT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that an overstitch nxt was used in the stomach to perform an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.The procedure was successfully completed.The same night, the patient experienced severe abdominal pain and was referred to a local hospital.The patient admitted herself to the hospital in the morning after the procedure.The treating physician was able to identify two perforations in the stomach.The overstitch sutures were removed and the perforations closed as part of an intervention.The intervention procedure was successfully completed.The patient's condition was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf code f19 captures the reportable event of surgical intervention.Imdrf code e2114 captures the reportable event of perforation.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.
Additional Manufacturer Narrative
Block h6: imdrf code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf code f19 captures the reportable event of surgical intervention.Imdrf code e2114 captures the reportable event of perforation.Additional information: block: d4: lot number, expiration date.H4: device manufacturing date.Ei: initial reporter phone.
Event or Problem Description
It was reported to boston scientific that an overstitch nxt was used in the stomach to perform an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.The procedure was successfully completed.The same night, the patient experienced severe abdominal pain and was referred to a local hospital.The patient admitted herself to the hospital in the morning after the procedure.The treating physician was able to identify two perforations in the stomach.The overstitch sutures were removed and the perforations closed as part of an intervention.The intervention procedure was successfully completed.The patient's condition was reported to be fully recovered.

• 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): VIANT MEDICAL INC; grand rapids MI 49504
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22331850
• Report Number: 3005099803-2025-02885
• Device Sequence Number: 18496232
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K231553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/08/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2025020048
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 02/12/2025
• 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; Hospitalization
• Patient Sex: Unknown