The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.The amplatzer vascular plug ii instructions for use (ifu) states the amplatzer vascular plug ii is indicated for arterial and venous embolizations in the peripheral vasculature.The ifu warns that the safety and effectiveness of this device for cardiac use (for example, paravalvular leak closures) has not been established.
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