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

Model Number XTACK-160-H

Device Problem Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

Combined medwatch submitted to the fda on 08/sep/2023.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of suture broke during procedure as follows: warning: do not introduce the device with the needle body in its open position.Warning: ensure appropriate suture slack has been created for desired suture path and pattern.Advance anchor exchange and/or manipulate endoscope to create suture slack.Anchor exchange will not install anchor onto the needle body: i.Ensure there is sufficient suture slack, and the suture outside endoscope is not entangled.Ii.Ensure anchor exchange is properly positioned in alignment tube of needle driver.Warnings: only physicians possessing sufficient skill and experience in similar, or the same techniques should perform endoscopic procedures.Note: ensure suture is not tangled after removal from the cartridge.Caution: do not use when valve covers are closed as suture drag will be increased.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Ensure that there is sufficient space for the needle to open.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.The subject product met all specifications and requirements in effect at the time of manufacture for both lot numbers af05479 and af05239.There are no other complaints against these lot numbers, af05479 and af05239, and allegation.Device evaluation summary: (b)(6) 2023.One xtack was returned with no additional components.The lot number of the returned device could not be identified.Engineering visually and inspected the returned device.Visual observation did not find any discrepancies.Under microscopic analysis, the ball is present on the distal end of the device.The handle works as intended, as the tip rotates, and the distal end retracts.The complaint could not be verified as the returned device does not show any abnormalities.Lab analysis was not able to replicate the reported event of "suture assembly-suture broke during procedure", as the returned device does not show any abnormalities.The user effects of "suture assembly-suture broke during procedure" is known and labeled possible adverse event.The second device informatiion is as follows: d.4 model number : xtack-160-h; catalog number xtack-160-h:d; lot number af05239; udi number (b)(4); expiration date 9/26/2025: h.4 manufacturing date: 9/26/2022;.

Event Description

Healthcare professional reports two sutures fell apart upon cinching.Procedure successfully completed with competitive device.Patient is doing well.Of the two devices reported, only one was returned for analysis for which the lot number could not be identified.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC 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: 17714385
• MDR Text Key: 323002738
• Report Number: 3006722112-2023-00171
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020763
• UDI-Public: (01)10811955020763(17)20260314(11)20230314(10)AF05479
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF05479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 100 KG