On (b)(6) 2016, a 20 mm amplatzer septal occluder (aso) was implanted; however, it was found and embolized within a few days.On (b)(6) 2016, the aso was removed percutaneously and a larger 22 mm aso was placed successfully.The patient was reported to be stable.
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(b)(4) the results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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