MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM

Device Problem Migration (4003)

Patient Problem Peritonitis (2252)

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 10/apr/2023.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 "perforation" as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.Contraindications include those specific to use of an endoscopic suturing system, and any endoscopic procedure, which may include, but not limited to, the following: this system is not for use where endoscopic techniques are contraindicated.This system is not for use with malignant tissue.Adverse events: 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, death.Any serious incident that has occurred in relation to the device should be reported to apollo endosurgery (see contact information at the end of this document) and any appropriate government entity.Additional information: the device will not be returned for analysis, and since it is not possible to gather more information from the reporter, no additional information will be received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.

Event Description

Report from an literature review.It was report that two patients had the following symptoms: patient 1 male - showed to have a migration of a stent to the distal ileum.Prior to elective removal the patient developed peritonitis and pneumoperitoneum and was then taken for emergent diagnostic laparoscopy with small bowel resection and primary anastomosis.Six days later the patient was discharged, patient doing well.Patient 2 female - laparoscopy with suture of the perforated duodenal ulcer and subsequent worsening sepsis and reoperation with laparotomy, tube duodenostomy and drainage was performed.Subsequently accidental dislodgement of the duodenostomy tube five days later prompted endoscopic intervention and niti-s pyloric / duodenal covered stent 10 cm 22 mm was deployed in pylorus and duodenum.Following clinical recovery and discharge, patient was readmitted five weeks later with obstructive symptoms requiring laparotomy and segmental resection of mid small bowel and stent extraction.Following uncomplicated recovery, the patient was discharged 6 days later.

Manufacturer Narrative

Supplement #x medwatch submitted to the fda on 19/apr/2023.Additional information: the device will not be returned for analysis, and since it is not possible to gather more information from the reporter, no additional information will be received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Type of Device: ENDOSCOPIC SUTURE SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 16707186
• MDR Text Key: 312962210
• Report Number: 3006722112-2023-00076
• Device Sequence Number: 1
• Product Code: OCW
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization