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

Model Number ESS-G02-160

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

Further information has been requested from the presenter regarding: additional information regarding the reported event, physician information, patient information, and device information.The presentor indicated that they had not seen this patient, and that they would not provide the name of the patient's treating physician.A review of the instructions for use notes the following: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: · death.

Event Description

Reported during a medical conference presentation: a patient who underwent an endoscopic sleeve gastroplasty (esg) utilizing the overstitch endoscopic suturing system was noted to have died (pulmonary embolism).Additional information reported, "patient did well after the procedure.[they were] seen in clinic on day 2 without any complaint.However, 5 days after the procedure [the patient] died.".

Manufacturer Narrative

Supplement #1 - medwatch submitted to the fda on 25/mar/2020.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 8701844
• MDR Text Key: 148133255
• Report Number: 3006722112-2019-00131
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 79