MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Irritation (1941); Pain (1994)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The balloon was noted to be discolored as the shell and center patch were dark blue in appearance.White particles were observed on the outer surface of the shell.Red particles were noted on the inner surface of the valve channel.A valve test was performed and the flow of fluid was not continuous and was obstructed.As the valve was blocked and air leak test was not feasible.Under microscopic analysis note the opening on the posterior portion of the shell was noted to have striated edges, consistent with surgical damage during device removal activities.A review of the device labeling notes the following: warnings and precautions: the physiological response of the patient to the presence of the orbera® 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, gastric and esophageal perforation, and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Possible complications - possible complications of the use of orbera® include: adverse health consequences resulting from weight loss.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.Gastroesophageal reflux.Bacterial growth in the fluid which fills the balloon.Rapid release of this fluid into the intestine could cause infection, fever, cramps and diarrhea.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.-spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.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.

Event Description

Reported as: a patient with the orbera intragastric balloon had "endoscopic examination performed for the purpose of intragastric balloon removal; loss of 12kg; appearance of recent abdominal pain.The aab shows that the balloon has distended itself with air.Exam performed under general anesthesia with intubation.Description of the examination: dilaceration of the mucosa at the level of the cardia.Which dry up spontaneously.Normal appearance of the gastric mucosa.Withdrawal of an intragastric balloon of 650ml.".

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: tracy whisman ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8911485
• MDR Text Key: 155569835
• Report Number: 3006722112-2019-00146
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF01199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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): Required Intervention