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

Model Number	XTACK-160-H
Medical Device Problem Codes	Separation Problem (4043); Premature Separation (4045)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006722112-0230-00232
• Device Sequence Number: 20500184
• Product Code: OCW
• UDI-Device Identifier: 10811955020763
• UDI-Public: (01)10811955020763(17)20230125(11)20200125(10)AF04884
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K201808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG