It was reported, the physician selected a gore® cardioform septal occluder to close a patent foramen ovale (pfo) on (b)(6) 2019.The device was placed but did not look right.It was high and horizontal but the discs were splayed so the device was locked and left in place.Approximately 10-15 minutes post procedure a pericardial effusion was noted.A pericardial window surgical procedure was performed to drain excess fluid from the pericardium.The following day the patient was sent to a larger hospital for surgical device removal.The device was not on the atrial septum but was removed from a hole in the dome of the left atrium.The patient was doing well following the procedure.
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