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

Model Number B-4800

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 10/15/2017

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.Device labeling addresses the reported events as follows: precautions: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain.Patients will need to immediately contact their physician for any severe or unusual symptoms.Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed during this adjustment period.These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications.Typically the stomach acclimates to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications prophylactically (before orbera® placement).Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms.The physiological response of the patient to the presence of orbera® 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.Patients need to be evaluated and the device removed at or within 6 months of placement.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications of the use of orbera® 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.Spontaneous over inflation.Warnings: spontaneous over inflation of an indwelling balloon has been reported in patients with orbera®.Symptoms of balloon over-inflation include 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.

Event Description

Reported as: a patient in the (b)(6) post-approval study (opas) had experienced nausea and pain.The patient was hospitalized.Physician confirmed serious ae inflation and the balloon was removed.

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 04/26/2018.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 09/nov/2017.A visual examination was performed on the received balloon and container with tubing.The container with tubing was wiped thoroughly with ipa 70/30 solution and disposed of into the biohazard waste.The balloon was noted to be discolored, as the shell and center patch were orange in appearance.Black, green, orange, white, and yellow particulate matter were observed on the inner and outer surfaces of the balloon shell.Black and red particulate matter was observed on the outer surface of the center patch.As the balloon was not received with the fill tube, 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 six separate openings on the radius of the shell.Under microscopic analysis, all six openings on the radius of the shell were noted to have striated edges, consistent with surgical damage from device removal activities.Brown particulate matter was observed on the inner surface of the valve channel.Brown and black particulate matter was noted on the outer surface of the center patch.Black and brown particles were noted on the inner surface of the balloon shell.Black, brown, and transparent particulate matter was observed on the outer surface of the balloon shell.

• 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: 6993977
• MDR Text Key: 91315916
• Report Number: 3006722112-2017-00378
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/17/2019
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF00643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FERROUS SULFATE SUPPLEMENT; MEDICATION FOR DEPRESSION/ANXIETY; MEDICATION FOR GASTRITIS; MEDICATION FOR INDIGESTION; MEDICATION FOR INSOMNIA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 117