(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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On (b)(6) 2015, a 7 mm amplatzer septal occluder (aso) was implanted.On (b)(6) 2015, it was determined the device had embolized into the descending aorta at an unknown point in time.On (b)(6) 2015, the aso was surgically removed.The patient was reported to be stable following the procedure.
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