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

Model Number	PLY-G02-020-APL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the course of the patient's treatment, the patient reported a loss of restriction and a lack of weight loss.A follow up endoscopy was conducted in (b)(6) 2026.The physician observed that the sutures were no longer in place.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6 device code a0401 is being used to capture the reportable event of suture break.
Additional Manufacturer Narrative
Block d4, h4 detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6 device code a0401 is being used to capture the reportable event of suture break.Additional information block a1, a2, a3a, a3b, b5 updated based on additional information received on march 05, 2026.Device evaluation block h11 the overstitch suture was not returned and no media was available for analysis.Product analysis could not be performed, for this reason and due to the lack of evidence, the reported event of suture break could not be confirmed.A risk review of the overstitch suture was completed and confirmed that the events of suture break, therapeutic response decreased and endoscopic procedure were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) could not be performed because the ship history review could not be completed due to the unavailable documentation.Based on all gathered information, there is not enough evidence to determine whether the suture break was due to the physician's technique during the procedure or was related to a device malfunction.For the events therapeutic response decreased and endoscopic procedure, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.All compiled information on this investigation determines that the most probable cause is "unable to exclude device problem".
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the course of the patient's treatment, the patient reported a loss of restriction and a lack of weight loss.A follow up endoscopy was conducted on (b)(6) 2026.The physician observed that the sutures were no longer present, indicating a suture failure.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the course of the patient's treatment, the patient reported a loss of restriction and a lack of weight loss.A follow up endoscopy was conducted on (b)(6) 2026.The physician observed that the sutures were no longer present, indicating a suture failure.There was 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.Additional information block b7 and d4 updated based on additional information received on march 25, 2026.

• 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 ; 9145716918
• MDR Report Key: 24462605
• Report Number: 3005099803-2026-00756
• Device Sequence Number: 21184879
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)241216(17)291216(10)24SE12547
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K191439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 06/02/2026

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: 24SE12547
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 03/25/2026; 05/08/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/20/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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 Age: 40 YR
• Patient Sex: Female