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

Model Number XTACK-160-H

Device Problems Separation Problem (4043); Premature Separation (4045)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

Combined medwatch submitted to the fda on 07/dec/2023.Clinical study: 01 - 016.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 premature separation of tack as follows: the x-tack¿ system is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.G.Closure and healing of esd/emr sites, and closing of fistula, perforation or leaks).Precautions the system may only be used if purchased from apollo endosurgery, inc.Or one of its authorized agents.Advance device catheter and push helix tack against tissue.Caution: ensure the handle is in reset.Position prior to driving helix tack.Note: do not retract device catheter from.The working channel whilst a helix tack is installed; this could lead to device damage or inadvertent detachment.Additional information: the device has not been returned for analysis.Dhr review was completed for lot number, af04884.The subject product met all specifications and requirements in effect at the time of manufacture.There was one other complaint in the apollo database against this lot number, af04884.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.

Event Description

Premature of track not used.Inadequate anchoring of x-tack constructs.Ovesco 11/6t, 1 clip(competitors device) used in the case to close the perforation of the esophagus.Mucosal defect closure device.

• Brand Name: X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS
• Type of Device: ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS
• 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: 18283636
• MDR Text Key: 329950346
• Report Number: 3006722112-0230-00232
• 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: 07/25/2023

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: 01/25/2023
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF04884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG