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

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Failure to Align (2522); 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	04/28/2025
Type of Reportable Event	Malfunction
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, after grabbing the tissue the system was not closing to perform the stitch.It found the arm was not aligned, alligator forceps were used to retrieve the anchor from the needle shaft.The procedure was completed with another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 imdrf code f2301 is being used to capture the reportable event of additional device required.Device code a1702 is being used to capture the reportable event of failure to retrieve anchor.
Additional Manufacturer Narrative
Block h6: imdrf code f2301 is being used to capture the reportable event of additional device required.Device code a1702 is being used to capture the reportable event of failure to retrieve anchor.Block h11: the returned overstitch nxt endoscopic suturing system was analyzed.The reported events of needle shaft failure to align and anchor exchange failure to retrieve anchor could be confirmed.During analysis, the device was observed with the encap tape hooks detached and the needle body bent, which was most likely caused by procedural factors that led to the damage.Installing the anchor onto the needle body having the anchor exchange too far distal and closing the needle body, may cause the anchor crashing against the anchor exchange, causing the needle body to bend, leading to the needle shaft failure to align and the anchor exchange failure to retrieve anchor.Based on all the gathered information, the most probable cause selected is adverse event related to procedure, since the device was returned with the needle body bent, most likely procedural factors as handling of the device.A labeling review was performed, there is no evidence the device was improperly used per the 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 was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025 during the procedure, after grabbing the tissue the system was not closing to perform the stitch.It found the arm was not aligned, alligator forceps were used to retrieve the anchor from the needle shaft.The procedure was completed with another device of the same model.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22052090
• Report Number: 3005099803-2025-02216
• Device Sequence Number: 8908309
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893(11)250114(17)271231(10)2025010032
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/20/2025

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: 2025010032
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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
• Patient Sex: Unknown