MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-50000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Abdominal Distention (2601)

Event Date 04/10/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device labeling notes the following: the current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain " and "bloating" as follows: "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.Abdominal or back pain, either steady or cyclic.".

Event Description

Patient presented distended abdomen and pain.Balloon was removed.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 13/jan/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 10/nov/2020.A deflated balloon with blue/brown coloring and white particles were present on the shell.As the device was not received with the fill tube, a sample fill tube was used for device testing and there were no blockages noted.The flow of liquid through the slit valve was continuous and unobstructed.An air leak test was not feasible as there are several small slits on the shell.Under microscopic analysis, the small holes on the shell have jagged edges which is consistent with a surgical removal instrument.The complaint is related to physiological issues and not the functionality of the balloon.

• Brand Name: ORBERA 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: 10503579
• MDR Text Key: 206107501
• Report Number: 3006722112-2020-00075
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF03283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 94