MAUDE Adverse Event Report: APOLLO ENDOSURGERY TISSUE HELIX; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	THX-165-028
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6.Imdrf device code a150207 is being used to capture the reportable event of helix failure to remove.Imdrf impact code f2301 is being used to capture the reportable event of a snare used to remove the helix.
Event or Problem Description
It was reported to boston scientific corporation that a tissue helix was used with overstitch during a procedure on (b)(6) 2025.During the procedure, the helix became embedded in tissue.The procedure was completed by using a snare to remove the helix.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 is being used to capture the reportable event of helix failure to remove.Imdrf impact code f2301 is being used to capture the reportable event of a snare used to remove the helix.Block h11: device evaluation- the tissue helix was not returned; however, media analysis was completed.Pictures were provided by the customer where it can be observed the tissue helix outside the pouch, along with the device label information showing the batch and upn number.The reported event of helix failure to remove could not be confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on all gathered information, the most probable root cause selected is unable to exclude device problem, because there is not enough evidence to determine whether the helix failure to remove was due to the physician's technique during the procedure or was related to a device malfunction.For the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.
Event or Problem Description
It was reported to boston scientific corporation that a tissue helix was used in the stomach with overstitch during a procedure on (b)(6) 2025.During the procedure, the helix became embedded in tissue.The procedure was completed by using a snare to remove the helix.There was no patient complications reported as a result of this event.

• Brand Name: TISSUE HELIX
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23519557
• Report Number: 3005099803-2025-05884
• Device Sequence Number: 9632800
• Product Code: OCW
• UDI-Device Identifier: 20811955020685
• UDI-Public: (01)20811955020685(11)230509(17)260509(10)AF05546
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2026
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF05546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 05/09/2023
• 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 Sex: Unknown