MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Perforation (2001); Sepsis (2067); Vomiting (2144)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 08/jan/2021.The reporter noted that the device will not be returned for analysis.The reporter also mentioned that the patient was sent to the intensive care unit but is now in a regular ward.The patient was diagnosed with sepsis and is being treated with antibiotics.The patient had about 20% of their stomach removed but is expected to make a full recovery.A review of the device labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "stomach perforation / erosion", and "vomiting" as follows: warnings and precautions: the physiological response of the patient to the presence of the orbera365¿ system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Possible complications of the use of the orbera365¿ system include: injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.Complications of routine endoscopy include: digestive tract injury or perforation.

Event Description

Patient presented with vomiting, sepsis and gastric perforation.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 05/feb/2021.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 11141375
• MDR Text Key: 225827336
• Report Number: 3006722112-2020-00134
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03885
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 113