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	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf code a0401 captures the reportable event of suture break.
Event or Problem Description
This report pertains to second of two overstitch suture used during the same procedure.It was reported to boston scientific that an overstitch suture was used in an esg procedure on (b)(6) 2025.During the procedure, the physician experienced (2) sutures breaking with little to no tension.No patient complications were reported as a result of the event.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of suture break.Evaluation summary: the overstitch suture was not returned for analysis.With all the available information, boston scientific concludes that the most probable cause assigned is cause not established.In the customer provided pictures, it can be observed the suture is detached from the anchor.However, the reported event of suture break cannot be confirmed with the evidence provided by the customer.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.All compiled information on this investigation determines that the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific that an overstitch suture was used in an esg procedure on (b)(6) 2025.During the procedure, the physician experienced (2) sutures breaking with little to no tension.No patient complications were reported as a result of the event.The procedure was completed with another of the same device.This report pertains to first of two overstitch sutures used during the same procedure.

• 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: 21561541
• Report Number: 3005099803-2025-00926
• Device Sequence Number: 14546386
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: 10811955020732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 24SE6121
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 04/20/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 06/10/2024
• 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: Unknown