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

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Vomiting (2144)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications: possible complications of the use of the orbera system include: 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.

Event Description

Reported as: a patient with the orbera intragastric balloon had sudden vomiting and distension of the stomach.X-ray and digestive endoscopy was performed and confirmed hyperinflation of the balloon.The device was explanted and the patient requested a replacement device at future date.

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 01/10/2019.Additional information: device evaluation summary: a visual examination was performed on the returned balloon.The balloon was noted to be discolored, as the shell was blue in appearance.Grey and blue particulate matter was noted to be present in the valve channel.The device had a large tear covering approximately 25% of the radius of the shell.As the fill tube was not returned with the device, a sample fill tube was used for device testing.A valve test was performed, and the flow of di water was continuous and unobstructed.An air leak test was performed, and the balloon was noted to be leaking from the large tear on the radius of the shell.Under microscopic analysis, the large tear on the radius of the shell was observed to have a striated origination point, consistent with damage from a surgical tool.Brown and yellow particulate matter was observed on the inner surface of the slit valve.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 8155724
• MDR Text Key: 130498393
• Report Number: 3006722112-2018-00326
• 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: 01/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2925442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 78