(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 abbott 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) 2017, the 26 mm amplatzer septal occluder (aso) was implanted.On (b)(6) 2017, the aso was noted to have embolized into the left atrium.The embolized device was explanted and the septal defect was surgically closed.The patient was reported to be in stable condition.
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