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

Model Number ESS-G02-160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 09/24/2023

Event Type  malfunction  

Event Description

Eport of patient death.It was report that two weeks after the balloon was implanted that the patient was not feeling good and went to the er and were tac showed blood and liquid in the abdomen.The patient was discharged from the er the next day, the patient passed away.Autopsy result tm was informed about says that death was caused by a heart attack / stroke.

Manufacturer Narrative

Initial medwatch submitted to the fda on 30/oct/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 "death" as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.The overstitch is compatible with the following endoscopes: olympus 2t160, 2th180, or 2t240.Fuji ei-740d/s.Availability of compatible devices may vary depending on geography.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.Note: 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 has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.

Event Description

Report of patient death.It was report that two weeks after the esg procedure that the patient was not feeling good and went to the er and a tac showed blood and liquid in the abdomen range.The patient was discharged from the er the next day, the er discharged the patient and the next day the patient passed away.Apollo tried to reache out to the doctor several time and the doctor did not want to discuss the case.An autopsy was performed but we were not allowed to get a copy of the report.The territory sale manger was informed about says that death was told the cause of death was not due to the device it was due to an heart attack / stroke.

Manufacturer Narrative

Supplement 02 medwatch submitted to the fda on 15/dec/2023.Areview of the device labeling notes the folowing: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "death" as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.The overstitch is compatible with the following endoscopes: · olympus 2t160, 2th180, or 2t240 · fuji ei-740d/s availability of compatible devices may vary depending on geography.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.Note: 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.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.

Event Description

Report of patient death.It was report that two weeks after the balloon was implanted that the patient was not feeling good and went to the er and were tac showed blood and liquid in the abdomen.The patient was discharged from the er the next day, the patient passed away.Autopsy result tm was informed about says that death was caused by a heart attack / stroke.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 06/nov/2023.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.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 SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING 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: 18031341
• MDR Text Key: 326868974
• Report Number: 3006722112-2023-00206
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: (01)10811955020664
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• 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): Death
• Patient Age: 38 YR
• Patient Sex: Female