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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an overstitch suture was utilized during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026 for the treatment of obesity.During the procedure, while pulling the suture before cinching, the thread broke and became detached from the needle shaft.Procedure was completed with another of the same device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of suture break.Investigation summary the overstitch suture was not returned; therefore a technical analysis could not be performed.For this reason and due to the lack of evidence, it is not possible to confirm the reported event of "suture break" and "anchor detachment of device or device component".A similar complaint review was completed.There were no emerging trends identified that warrant further action.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.In regard to event description and information provided by the customer there is not enough evidence to determine whether the suture break and anchor detachment of device or device component were due to the physician's technique during the procedure or was related to a device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25800962
• Report Number: 3005099803-2026-02782
• Device Sequence Number: 17605394
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)250310(17)300310(10)25SE02958
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K191439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 25SE02958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 03/10/2025
• 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