(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, an asd closure procedure was performed.The defect was measured on toe at 6 mm and this 7 mm amplatzer septal occluder (aso) was prepared as normal and deployed in the defect.The aso was reviewed, considered to be stable, and was released.Five minutes after release, the aso embolized to the descending aorta.The aso was snared and removed via the left femoral artery.The defect was then measured using a sizing balloon and found to be 10 mm.An 11 mm aso was then successfully deployed with no further problems.Per report, there were no patient consequences.
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