MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-160

Device Problem Migration (4003)

Patient Problems Pain (1994); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 28/apr/2021.After multiple attempts to gather more information from the reporter, no additional information has been received.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "other-clinical outcome device related" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: pharyngitis / sore throat.Nausea and / or vomiting.Abdominal pain and / or bloating.Hemorrhage.Hematoma.Conversion to laparoscopic or open procedure.Stricture.Infection / sepsis.Pharyngeal, colonic and/or esophageal perforation.Esophageal, colonic and/or pharyngeal laceration.Intra-abdominal (hollow or solid) visceral injury.Aspiration.Wound dehiscence.Acute inflammatory tissue reaction.

Event Description

Medical information review of literature: effectiveness of combination endoscopic therapy for colonic anastomotic leaks.Author: thiruvengadam, nr.Et al.Abstract: background colonic anastomotic leaks are associated with significant morbidity and mortality.Whereas small case series suggest that fully covered self-expandable metal stents (fcsems) are effective, no larger studies have examined the impact of combination endoscopic therapy on colonic anastomotic leaks.Methods our retrospective cohort study reviewed 51 patients undergoing endoscopic therapy for colonic anastomotic leaks between 2011 and 2018.Patients receiving combination therapy involving fcsems plus local closure (n = 24) were compared with patients receiving fcsems alone (n = 18) or endoscopic suturing alone (n = 9).The primary outcomes were technical and clinical success (resolution of leak, removal of percutaneous drains, avoidance of surgical reoperation, and reversal of temporary diversion).Results clinical success was achieved in 55% of patients.Clinical success was achieved in 18/24 patients (75%) with combination therapy compared with 6/18 patients receiving fcsems alone (33%, adjusted risk ratio [rr] 2.16, 95% confidence interval [ci] 1.10 - 4.24; p = 0.02) and 4 /9 patients undergoing endoscopic suturing alone (44%, rr1.91, 95 %ci 0.84 - 4.31; p = 0.10).Stent migration occurred in 40% of patients.Conclusions this large series demonstrates that combination therapy was associated with a higher rate of clinical success, and future prospective studies are warranted.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): VIANT MEDICAL; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 11741766
• MDR Text Key: 261959247
• Report Number: 3006722112-2021-00033
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081853
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• 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