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U.S. Department of Health and Human Services

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

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APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM Back to Search Results
Model Number B-4800
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Nausea (1970); Pain (1994); Perforation (2001); Obstruction/Occlusion (2422)
Event Date 04/10/2019
Event Type  Injury  
Manufacturer Narrative
The physician indicated the device will not be returned to apollo for analysis as the device has been discarded.A review of the device labeling notes the following: 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.Clinical data does not exist to support use of an individual orbera¿ beyond 6 months.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 - 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, delayed gastric emptying and/or 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.Gastric outlet obstruction.A partially-filled balloon (i.E., <400 cc), or a leaking balloon could lead to gastric outlet obstruction, requiring balloon removal.It is also possible for a fully inflated (400-700 cc) balloon to lodge itself in the gastric outlet causing a pyloric obstruction which can produce a mechanical impediment to gastric emptying.Gastric outlet obstruction may require surgical removal.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.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 with the orbera intragastric balloon had their balloon placed approximately one month ago and had been doing fine.Patient contacted the physician and said 48 hours earlier they had a great deal of nausea and was concerned.Physician suggested they go to the er.An x-ray showed a massively dilated stomach with a great deal of stomach contents.The er doctor placed the ng tube but was unable to remove any stomach contents.The patient was given morphine for pain.The patient was able to go to their physician to get the device removed.Upon removal the physician noted he had to place a ng tube because there was a great deal of stomach contents (undigested food and liters of fluid), none of which was getting around the balloon.He said he had a difficult time visualizing the balloon even after removing as much as the stomach contents as possible.Due to the challenge to visualize the balloon he had to make 3 attempts to puncture the balloon to finally remove.The procedure went well considering he had to work hard to visualize and stabilize the balloon to puncture and aspirate the fluid for removal.The patient started to experience upper stomach pressure but no pain the following day.The patient went to the er nearby and was assessed via x-ray which showed free air in the abdominal cavity, the patient had a small stomach perforation.The patient was taken via ambulance to a nearby hospital where they had laparoscopic surgery to repair the perforation.The physician also noted the balloon measured 13.5 cm on the x-ray, he did not get a good enough visual of the balloon to see if it was air or fluid but the balloon was a bigger dilated balloon then the size that he placed.
 
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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
Manufacturer (Section G)
APOLLO ENDOSURGERY COSTA RICA, SRL
coyol free zone
building b 13.3
alajuela,
CS  
Manufacturer Contact
laura leboeuf
1120 s. capital of texas hwy
bldg 1, ste. 300
austin, TX 78746
MDR Report Key8591761
MDR Text Key144444800
Report Number3006722112-2019-00110
Device Sequence Number1
Product Code LTI
UDI-Device Identifier10811955020619
UDI-Public10811955020619
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 04/12/2019
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 Date10/12/2020
Device Model NumberB-4800
Device Catalogue NumberB-4800
Device Lot NumberAF02184
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2019
Initial Date FDA Received05/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age36 YR
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