(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) 2016, a 12mm amplatzer septal occluder (aso) was implanted.Later the same day, the aso was found embolized in the aorta.The patient was returned to the cath lab and the aso was snared successfully.The patient was stable post-procedure and will be re-evaluated for percutaneous or surgical closure at a later date.
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