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 Codes	Erosion (1750); Gastritis (1874); Inflammation (1932); Pain (1994)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
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 (esg) procedure performed on (b)(6) 2023.During emergent follow-up after the 2023 esg procedure, the patient underwent an endoscopy to evaluate stomach pain.The endoscopy reportedly diagnosed erosive gastritis and identified excessive wires and plastic within the stomach.The patient reported that the implanted stitches appeared to have come undone; however, it was unknown whether the observed materials were contributing to the stomach irritation.The materials observed on gastroscopy were identified as overstitch/suture material following the primary procedure in (b)(6) 2023.The patient was treated with proton pump inhibitor therapy.The original esg procedure was completed with the original devices, and no device issues were reported during the procedure.The patient remained clinically stable following the initial procedure and experienced an excellent initial recovery for the first 18 months post-procedure until the onset of abdominal pain.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information; the device was used before its expiration date and the lot is unavailable.Because the product lot is unavailable, 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.Imdrf code f2202 is being used to capture the reportable event of endoscopic 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): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50233692
• Report Number: 3005099803-2026-03300
• Device Sequence Number: 13326260
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Model Number: PLY-G02-020-APL
• Device Catalogue Number: PLY-G02-020-APL
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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
• Patient Weight: 160 LB