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

Model Number ESS-G02-NXT

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a1702 captures the reportable event of difficulty advancing the overstitch through the overtube.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturing report number for the overstitch nxt endoscopic suturing system and 3005099803-2024-01220 for the overtube endoscopic access system.It was reported to boston scientific corporation that an overstitch nxt endoscopic suturing system was used in a transoral outlet reduction (tore) performed on (b)(6) 2024.During the procedure, there was some resistance when maneuvering the overstitch through the overtube and it was noted that the overtube was torn.It was reported that there was less inflation than they wanted.In the physician's assessment the resistance and maneuvering may have caused the tear.The procedure was successfully completed with these devices.There were no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): VIANT MEDICAL INC; 620 watson st sw; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18956020
• MDR Text Key: 338311698
• Report Number: 3005099803-2024-01049
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: 10811955020893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-NXT
• Device Lot Number: 202311E011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1