The balloon inflation pressures were not provided.The device therapy occurred over 197 days which is beyond the labeled 6 month use.A potential root cause of the deflation could have been material fatigue resulting from low balloon pressure, however the actual root cause remains unknown.Per the labeling "patients reporting a loss of fullness, increased hunger, and/or weight gain should be examined by radiograph, as this may be a sign of balloon deflation.Additionally, any increase in nausea, vomiting and/or cramping after initial symptoms have subsided may indicate a deflated balloon.Endoscopic visualization might be required if the state of inflation cannot be determined radiographically.Evident balloon deflation may require early balloon removal".The instruction for use contains the following warning: "the risk of balloon deflation is significantly higher with balloons that are left longer than 6 months".
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Additional event information was obtained.The patient had the first balloon placed on (b)(6) 2018, second balloon placed on (b)(6) 2018, and the third balloon placed on (b)(6) 2018.A single deflated balloon and two inflated balloons were found in the stomach during the endoscopic removal on (b)(6) 2019.The patient did not report a new onset of symptoms to their prescribing physician.
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