MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC. WEIGHT LOSS SURGERY; ENDOSCOPIC SUTURING DEVICE FOR ALTERING GASTRIC ANATOMY FOR WEIGHT LOSS

Patient Problem Pyrosis/Heartburn (1883)

Event Date 07/21/2023

Event Type  Injury  

Event Description

Reporter called with complaint that he received endoscopic sleeve gastroplasty last year and that the surgery has completely failed.His appetite has not decreased, he has not lost any weight and he can still eat all the food that he desires.Additionally, he is now experiencing an increase in acid reflux, primarily when laying down to sleep.Reporter feels that the surgery was not done properly and does not know where the failure occurred.

• Brand Name: WEIGHT LOSS SURGERY
• Type of Device: ENDOSCOPIC SUTURING DEVICE FOR ALTERING GASTRIC ANATOMY FOR WEIGHT LOSS
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.
• MDR Report Key: 18758117
• MDR Text Key: 335999551
• Report Number: MW5151798
• Device Sequence Number: 1
• Product Code: QTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2024
• Patient Sequence Number: 1
• Patient Sex: Male