MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	PLY-G02-020-APL
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of suture break.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.During the procedure, after the seventh bite the suture broke when pulling the suture.The procedure was completed using another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of suture break.Block h11: the returned overstitch suture was analyzed.However, the suture was returned with the anchor detached and was not returned.For this reason, it was not possible to confirm the reported event.Based on all gathered information, the probable cause selected is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.During the procedure, after the seventh bite the suture broke when pulling the suture.The procedure was completed using another device of the same model.There were no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH 2-0 POLYPROPYLENE SUTURE
• 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): ASSUT EUROPE SPA; via giuseppe gregoraci 12; rome, rm 00137 ; IT 00137
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22370304
• Report Number: 3005099803-2025-03084
• Device Sequence Number: 4388844
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)240219(17)290219(10)24SE2214
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K191439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PLY-G02-020-APL
• Device Catalogue Number: PLY-G02-020-APL
• Device Lot Number: 24SE2214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Patient Sex: Male