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

Model Number	ESS-G02-160
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during a stent fixation procedure on (b)(6)2025.During the procedure, while trying to place the second suture, the physician had difficulty unloading the anchor from the needle body because it was bent.The physician removed the device, and a perforation was observed.Clips were placed to close the perforation.The patient is reported to be stable, however it was noted that the patient was hospitalized or their hospitalization was prolonged.Boston scientific has been unable to obtain additional information regarding the details of the hospitalization, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch endoscopic suture system was used during an esophageal stent fixation procedure on (b)(6) 2025.While placing the second suture, the physician had difficulty unloading the suture from the needle body.Upon inspection, both the needle body and the anchor were found to be bent.The device was removed, and a 1-2cm perforation was observed at the upper esophageal sphincter.Clips were placed to close the perforation.The stent fixation was completed.The patient is reported to be stable; however, it was noted that the patient was hospitalized for an unknown amount of time on (b)(6) 2025 as a result of the perforation.
Additional Manufacturer Narrative
Block h6.Device code a040609 is being used to capture the reportable event of needle shaft bent.Device code a1702 is being used to capture the reportable event of anchor exchange failure to retrieve anchor.Additional information, b5: information received on october 16, 2025, reported the specific location of the procedure.Information received on october 24, 2025, reported the size of the perforation, first day of hospitalization, and outcome of the stent fixation.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE 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: 23278126
• Report Number: 3005099803-2025-05149
• Device Sequence Number: 8853816
• Product Code: OCW
• UDI-Device Identifier: 20811955020661
• UDI-Public: (01)20811955020661(11)240611(17)270531(10)2024060258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• 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): 01/28/2026

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-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2024060258
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 06/11/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown