MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM; SUTURING SYSTEM

Model Number	XTACK-160-H
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pneumonia (2011); Sepsis (2067)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported x-tack device failued post procedure.Patient admitted to the hospital to repair defect leak as well as treat developed mediastinis, sepsis, pleural effusion, pneumonia and atelectasis.
Additional Manufacturer Narrative
Combined medwatch submitted to the fda on 02nov2023.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 investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being vigilance or mdr reportable.A device history record (dhr) review was completed for reporting purposes.There were no other complaints in the apollo database against this lot number and this allegation, (b)(4).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.The user effects of premature separation of tack, irritation/inflammation, infection, hsopitalization are known and labeled possible adverse event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Common Device Name: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 18055501
• Report Number: 3006722112-2023-00211
• Device Sequence Number: 7017842
• Product Code: OCW
• UDI-Device Identifier: 10811955020763
• UDI-Public: (01)10811955020763(17)20250906(11)20220906(10)AF05213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2023

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: 09/06/2025
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF05213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 50 KG