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

Model Number B-4800

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

Patient Problems Dehydration (1807); Dysphagia/ Odynophagia (1815); Vomiting (2144); Weakness (2145); Patient Problem/Medical Problem (2688)

Event Date 08/14/2017

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient.It is unknown if the device is available for return to apollo endosurgery for analysis.Apollo is unable to follow up with reporter as no contact information was provided and therefore unable to confirm the reported events with the patient's physician.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.To prevent ulcers, it is recommended that the patient start a program of oral proton pump inhibitors (ppis) for approximately 3-5 days prior to orbera® placement so a maximal gastric acid suppression effect will be present on the day of placement.It is recommended that the ppi dose be given sublingually after orbera® placement if nausea and/or vomiting are present.A regimen of 40 mg per day of an oral ppi should be continued as long as the orbera® is in place.Other medications that are started prophylactically should be continued after orbera® placement until they are no longer needed.Furthermore, subjects will be directed to avoid medications known to cause or exacerbate gastroduodenal mucosal damage.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.Us pivotal study: the event of dehydration was reported in the us pivotal clinical study and was experienced by 14.4% and the event of dysphagia was experienced by 3.1% of the participants.

Event Description

Reported as: a patient with the orbera intragastric balloon reported as: a patient with the orbera intragastric balloon reported "i received the orbera balloon after careful research and consultation with [two physicians].I asked about statistics, etc.From everyone in the office and was assured that i would more than likely have some side effects of nausea but the new medication emend would take it away and this md even said that many of the physician's patients feel well enough to go back to work the next day.Everyone was so upbeat about this balloon and my goal was to rid myself of diabetes that i consented to the placement.However, after paying for the procedure out of pocket, i had the procedure under the "research" umbrella and was told that i would get back if i had the placement, etc.I understood this and again reiterated my main goal was to get rid of diabetes.However, my life almost ended after [device implant] 2017.The first day of placement i was so medicated that i felt fair, however, the next several weeks left me clinging to life, literally i was unable to drink, eat, hold anything down, repeatedly calling the office only to be told that this was "normal".Definitely what i'd been told all along.I became so week from dehydration that my [spouse] had to carry me to the first appointment where i was begging to have the device removed and was told no by [physician] because [physician] was on call at another hospital and i would have to pay a lot of money if i took it out and [physician] continued to refuse and tell me that i would just have to ride it out and [physician] offered to give me an iv for [price].I agreed to the iv because i was unable to stand up from weakness and then the nurse nor two other surgeons were able to give me an iv because i was so dehydrated and sick from this device placement.When the needles were being removed, there was not even a blood spot because i was so dry.They then told me that they could not stick me anymore because they had stuck me 4 times and told me to leave and go home and drink water.I explained that i could not drink because i kept vomiting and all three shrugged their shoulders.One of the surgeons said "if this was my [spouse], this thing would definitely come out of [them] before [spouse] dies." the nurse left the room and then the business office came in to reprimand [surgeon] and [surgeon's] comment and told [surgeon] to leave.I then went home and back to bed and called the next day trying to schedule surgery, continuing to get pushed off until i told them that i would call the media and an attorney and it was finally scheduled and was removed, in the surgery center.The staff told me that only one person has been able to leave this device in and that everyone has the same reaction to this device.I lost two weeks of work because of being unable to stand up, most importantly i almost lost my life.The device is unsafe and should not be permitted for use in any country on any human being.It's a deadly device and has no business being in the human body.Also, after having it removed i received a letter from the doctor dismissing from [physician] practice for my "noncompliance" with [physician] weight management program.This is the biggest scam that i've ever seen or certainly experienced and i would appreciate an investigation to hopefully save someone else's life.As well, when i reported to the physician that the fda had recently released a report about this balloon [physician] replied that the fda reports were "profanity" and that as a physician has to report everything that happens against [physician] within 30 days whether or not [physician] was the surgeon.I asked about the death of these people and [physician] told me not to worry, i asked how could i not worry when i was having such bad side effects and [physician] told me i needed to stop getting myself "worked up".".

• 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6931125
• MDR Text Key: 88978540
• Report Number: 3006722112-2017-00333
• 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: consumer,other
• Type of Report: Initial

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: Physician
• Device Expiration Date: 08/04/2018
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF00090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention