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

Model Number	ESS-ESG-NXT
Medical Device Problem Codes	Entrapment of Device (1212); Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an overstitch nxt was used to treat cancer in the esophagus during a stent fixation procedure.During the procedure, the overstitch nxt tower got stuck on stent.The sutures were cut, and the device was slowly dislodged from the stent.No patient complications were reported as a result of the event.The procedure was completed with another overstitch nxt and agile stent.
Additional Manufacturer Narrative
Block h6: imdrf code f23 captures the reportable event of unexpected medical intervention.Imdrf code a150208 captures the reportable event of needle shaft stuck.
Additional Manufacturer Narrative
Block h6: imdrf code f23 captures the reportable event of unexpected medical intervention.Imdrf code a150208 captures the reportable event of needle shaft stuck.Correction: b5: describe event or problem.H6: device codes.
Event or Problem Description
It was reported that an overstitch nxt was used to treat cancer in the esophagus during a stent fixation procedure.During the procedure, the overstitch nxt tower got stuck on stent.The sutures were cut, and the device was slowly dislodged from the stent.No patient complications were reported as a result of the event.The procedure was completed with another overstitch nxt and agile stent.Note: the instructions for use (ifu) indicate that stent fixation is not on label in the us and the labeling states the device is not for use with malignant tissue.

• 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: 22327711
• Report Number: 3005099803-2025-02922
• Device Sequence Number: 13116322
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: (01)10811955020893
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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
• Patient Sex: Unknown