Medwatch sent to the fda on 11/29/2016.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Device labeling addresses the reported events as follows: precautions: patients must be advised that orbera is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of balloon placement increase the risk of balloon deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when balloons are inflated to larger volumes (greater than 700cc).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: possible complications of the use of orbera include: 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.
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