MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC -TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM

Model Number XTACK-160-H

Device Problem Insufficient Information (3190)

Patient Problem Neuralgia (4413)

Event Date 04/13/2022

Event Type  malfunction  

Event Description

Patient was admitted to the hospital on (b)(6) 2022 and was released on (b)(6) 2022 with no injuries.Then on (b)(6) 2022 patient reported pain it was found the patient had acute esophageal.

Manufacturer Narrative

Combined medwatch submitted to the fda on 07/dec/2023.Clinical study: 01 - 040.A review of the device labeling notes the following: the current x-tack¿ endoscopic helix tacking system instructions for use (ifu) addressed the known and potential events of "pain (esophageal)" as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic suture cinch-deployment difficulty.Possible complications that may result from using the endoscopic suturing system include, but may not be limited to: · pharyngitis / sore throat.· nausea and / or vomiting.· abdominal pain and / or bloating.· hemorrhage.· hematoma.· conversion to laparoscopic or open procedure.· stricture.· infection / sepsis.· pharyngeal, colonic and/or esophageal perforation.· esophageal, colonic and/or pharyngeal laceration.· intra-abdominal (hollow or solid) visceral injury.· aspiration.· wound dehiscence.· acute inflammatory tissue reaction.· death.Note: any serious incident that has occurred in relation to the device should be reported to apollo endosurgery and any appropriate government entity.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being reportable.There are no other complaints against this lot number, af04744, and allegation.The subject product met all specifications and requirements in effect at the time of manufacture.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• Brand Name: -TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM
• Type of Device: ENDOSCOPIC HELIX TACKING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 18284487
• MDR Text Key: 329957399
• Report Number: 3006722112-2023-00229
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF04744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 57 KG