MAUDE Adverse Event Report: Apollo Endosurgery OverStitch Suture Cinch; Endoscopic Tissue Approximation Device

Model Number	CNH-G01-000
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during a stent fixation procedure on (b)(6) 2026.During the procedure, the cinch failed to deploy.The procedure was completed when the physician manually deployed the cinch.There was no patient complications reported as a result of this event.Note: this is the first of two suturing cinches used in the same procedure.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during a stent fixation procedure on (b)(6) 2026.During the procedure, the cinch failed to deploy.The procedure was completed when the physician manually deployed the cinch.There was no patient complications reported as a result of this event.Note: this is the first of two suturing cinches used in the same procedure.***additional information received on 04 aug 2026*** the patient anatomy was the stomach and the indication for the procedure was prosthesis fixation.
Additional Manufacturer Narrative
Block h6: device code a150101 is being used to capture the reportable event of cinch failure to deploy.Imdrf code f2301 is being used to capture the reportable event of additional device required.Block h11: investigation results.The complaint device was not returned.Therefore, a technical analysis could not be performed.The documentation attached includes a picture where it can be observed the packaging of the device with the upn and batch number.However, it is not possible identify the device and issue reported.For this reason, it is unable to confirm the reported event of "cinch failure to deploy".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.A similar complaint review was completed.There were no emerging trends identified that warrant further escalation.Based on the event description and information provided by the customer there is not enough evidence to determine whether the cinch failure to deploy was due to the physician's technique during the procedure or was related to a device malfunction.Additionally, for the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".
Additional Manufacturer Narrative
Additional information: block b5 information received on 04 aug 2026 reported the indication and location of the procedure and that the patient was over the age of 18.Block h6: device code a150101 is being used to capture the reportable event of cinch failure to deploy.Imdrf code f2301 is being used to capture the reportable event of additional device required.Block h11: investigation results: the complaint device was not returned.Therefore, a technical analysis could not be performed.The documentation attached includes a picture where it can be observed the packaging of the device with the upn and batch number.However, it is not possible identify the device and issue reported.For this reason, it is unable to confirm the reported event of "cinch failure to deploy".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.A similar complaint review was completed.There were no emerging trends identified that warrant further escalation.Based on the event description and information provided by the customer there is not enough evidence to determine whether the cinch failure to deploy was due to the physician's technique during the procedure or was related to a device malfunction.Additionally, for the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• Brand Name: OverStitch Suture Cinch
• 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): Apollo Endosurgery Costa Rica S.R.L; alajuela, 02, ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough,, MA 01752 ; EI 01752 ; +1(914)571-6918
• MDR Report Key: 50003178
• Report Number: 3005099803-2026-03042
• Device Sequence Number: 16105497
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)240925(17)270925(10)AF06218
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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 Expiration Date: 09/25/2022
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF06218
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown