On (b)(6) 2019, a 24mm amplatzer septal occluder was implanted.The patient was experiencing multiple episodes of nausea and vomiting post procedure.On (b)(6) 2019, a follow-up echocardiogram was performed and noted the device has embolized.The patient was taken to the cath lab and the device was successfully retrieved without complications.A 28mm amplatzer septal occluder was successfully implanted.On (b)(6) 2020, a follow-up echocardiogram was performed and the device was in it's desired location.The patient was reported to be in stable condition.
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An event of embolization of a 24mm amplatzer septal occluder (aso) before being replaced by a 28mm aso was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The upsizing to a larger device following embolization is possible evidence of undersizing; however, based on the information received, the cause of the reported incident could not be conclusively determined.
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