(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 13 mm amplatzer septal occluder (aso) was implanted.The following day, the aso was noted to have embolized.On (b)(6) 2015, the aso was successfully snared and removed.The patient was reported to be stable.
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