This event is being re-submitted as the original medwatch 3500a form (3010805634-2018-00004) was not properly submitted on 12/20/2018 through the electronic submission gateway (esg) portal.Original narrative dated 12/20/2018: this event is being conservatively reported as reintervention in chd is an expected event in 12-15% of congenital cardiac patients according to peer reviewed clinical literature.The device was replaced with another cardiocel device.Due to lack of information, this event is not currently assessable.No additional actions required at this time.
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