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

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dehydration (1807); Nausea (1970); Pain (1994); Vomiting (2144); Cramp(s) (2193)

Event Date 10/05/2019

Event Type  malfunction  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.A review of the device labeling notes the following: the risk documentation for this device establishes the occurrence ranking for the reported event "inflation" as "remote", which is defined by apollo as.02% -.49% of complaints over units sold.A review for the intragastric balloon products for the failure mode "inflation" is performed during quarterly complaint analysis meetings (cam) and has demonstrated that global balloon inflation rate remains at "remote".Therefore, apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event, as referenced in the cam meeting slides.The current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain ", "vomiting", and "nausea" 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

Reported complaint: "the patient complained of nausea and vomiting beginning on (b)(6) 2019.On the attached report, the physician reported that the patient presents since the day of implantation ((b)(6) 2019) symptoms of nausea and vomiting.In the last week, she began to present abdominal pain, intensification of vomiting and cramps, with the impossibility of opening her hands today (hydroelectrolytic disturbance) - medical report on (b)(6) 2019.Physician performed abdominal x-ray that showed balloon hyperinflation.Patient opted for balloon removal and implantation after 30 days, after stabilizing hydroelectrolytic disturbance.".

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 23/dec/2019.The device was returned to the apollo device analysis laboratory on (b)(6) 2019.Analysis of the device is ongoing.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 10/jan/2020.Additional information: h3, h6, h10.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 14/nov/2019.A deflated, discolored balloon without the fill tube was received for evaluation.As the device was not received with the fill tube, a sample fill tube was used for device testing and found no blockages and the flow of di water was continuous and unobstructed.The balloon was inflated; however, due to a small hole in the shell the balloon slowly deflated.The shell had a small opening with striated edges which is consistent with a surgical instrument.

• 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
• MDR Report Key: 9476669
• MDR Text Key: 183692603
• Report Number: 3006722112-2019-00179
• 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: 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: 02/13/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF02518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/14/2019; 11/14/2019
• Supplement Dates FDA Received: 12/23/2019; 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 70