MAUDE Adverse Event Report: APOLLO ENDOSURGERY COSTA RICA, SRL ENDOSCOPIC SUTURING SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hematoma (1884); Nausea (1970); Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

Additional information: we are unable to contact the author of the literature review, although we are unable to confirm the actual device used we still want to report the event.A review of the device labeling notes the following: the current overstitch sx¿ endoscopic suturing system directions for use (dfu) addresses the known and anticipated potential event of "clinical outcome not device related" as follows: warnings: verify compatibility of endoscope size, endoscopic instruments and accessories and ensure performance is not compromised.Use of the system is only recommended when accompanied by an overtube.Verify compatibility of device with overtube prior to use.Only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.

Event Description

Background: endoscopic suture reduction of the gastrojejunal anastomosis (gj) is a minimally invasive approach to treat weight regain in patients with roux-en-y gastric bypass (rygb).Traditional transoral outlet reduction (tore) is focused on reducing the aperture of the gastrojejunal (gj) anastomosis, while the tubular transoral pouchplasty outlet reduction (ttore) approach consists of tabularization of the distal pouch utilizing an o-shape gastroplasty suturing pattern (figure 1).Objective: the primary aim of this study was to compare the short- and long-term weight loss between tore and ttore.Methods: retrospective analysis of a prospectively maintained database was conducted at a tertiary care bariatric center of excellence.The study included patients with history of rygb who had an endoscopic revision by tore or ttore and had follow-up data in their electronic medical record.The primary outcome was % total body weight loss (%tbwl), defined as the percent body weight loss in relation to the patient's weight at the time of the procedure.Results: a total of 131 patients were included (ttore=96, tore=35).Table 1 describes the baseline and procedural characteristics of the cohort.At 3, 9, 12, and 18 months, patients who had a ttore achieved significantly higher % tbwl compared to those who underwent a tore (8.7% vs 6.4%, p=0.0431 at 3 months; 9.5% vs 4.6%, p=0.0470 at 9 months; 7.7% vs 0.8%, p=0.00927 at 12 months; 7.5% vs -2.1%, p=0.0036 at 18 months).When compared to the procedure alone, concomitant use of weight loss medication did not result in significantly higher %tbwl except at 12 months for the ttore group (13.7% vs 6.1%, p=0.0400).The mean procedural time, including diagnostic portions of the procedure, was not significantly different between the ttore and tore groups (59.5 vs 53 minutes, p=0.0730).Overall adverse events were low (3%) and similar between both groups (p=0.3).These included 3 patients with refractory nausea and vomiting requiring endoscopic balloon dilation, and 1 patient with hematemesis (n=1) managed with endoscopic clip hemostasis.

• Brand Name: ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 12025505
• MDR Text Key: 262196865
• Report Number: 3006722112-2021-00059
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention