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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a1702 captures the reportable event of failure to retrieve anchor.
Event or Problem Description
It was reported that an overstitch nxt was used during an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.During the procedure when loading the first suture, the anchor exchange presented resistance to the needle transfer.When the transfer was attempted, the suture was cut (it was the first bite of overstitch).The procedure was completed with another overstitch nxt.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code a1702 captures the reportable event of failure to retrieve anchor.Additional information: e1: initial reporter phone number received october 20, 2025.Device evaluation the overstitch nxt was returned for analysis.It was observed that the needle shaft was in the anchor exchange.Additionally, it was identified that the tape hooks and sheath tapes of the device were detached and were not returned.During the functional test, the anchor exchange worked successfully for deploying and retrieving the anchor.A microscopic inspection confirmed no visual damage.Based on the available information, the device functioned as intended during anchor deployment and retrieval, and the reported event of failure to retrieve anchor could not be confirmed.Although damage to the catheter and end cap was observed, the characteristics of this damage are most consistent with procedural factors, including device handling and physician technique.As the anchor exchange mechanism operated successfully, no device malfunction was identified.Boston scientific concludes that the most probable cause is no problem detected.
Event or Problem Description
It was reported that an overstitch nxt was used during an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.During the procedure when loading the first suture, the anchor exchange presented resistance to the needle transfer.When the transfer was attempted, the suture was cut (it was the first bite of overstitch).The procedure was completed with another overstitch nxt.There were no patient complications reported as a result of this event.

• 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; 5079 33rd street; grand rapids MI 49512
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22481188
• Report Number: 3005099803-2025-03302
• Device Sequence Number: 18309991
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)240711(17)270630(10)2024070390
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-NXT
• Device Catalogue Number: ESS-G02-NXT
• Device Lot Number: 2024070390
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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
• Patient Sex: Female