MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

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

Patient Problems Nausea (1970); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

Initial medwatch sent to the fda.The device was returned to apollo on 17/feb/2020.Analysis of the device is ongoing.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 event of "nausea", "vomiting" and "intolerance" 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 he 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: "patient sent to emergency ward for help due to severe intolerance.Vomiting, nausea.".

Manufacturer Narrative

Supplement #2-medwatch sent to the fda on 17/jun/2020.Device evaluation summary:the device was returned to the apollo device analysis laboratory on 17/feb/2020.A balloon was received deflated and the fill tube was not returned for evaluation.As the device was not received with the fill tube, a sample fill tube was used for device testing and there was no blockage observed and the flow of di water was continuous and unobstructed.An air leak test was performed; however, due to the hole on the shell the balloon slowly deflated.The hole on the shell shows jagged edges which is consistent with surgical equipment for removal.There were no discrepancies observed during functional evaluation that contributed to the reported event.The hole on the shell was created for removal purposes.

Manufacturer Narrative

Supplement #1-medwatch sent to the fda on 17/mar/2020.The device was returned to apollo on 17/feb/2020.Analysis of the device is ongoing.

• Brand Name: ORBERA 365 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
• MDR Report Key: 9782670
• MDR Text Key: 182191559
• Report Number: 3006722112-2020-00032
• 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,Followup
• Report Date: 06/17/2020

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: 08/07/2021
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 02/07/2020; 02/17/2020
• Supplement Dates FDA Received: 03/17/2020; 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 80