Safety management and adverse events
PFO, Thrombocytopenia, vascular dissection, aneurysm, Shock, rupture, Hemothorax, arrhythmias, hematoma, hemolysis, allergic reactions, arteriovenous fistula
BLEEDING, THROMBOCYTOPENIA, ARTERIAL DISSECTION, PHRENIC NERVE PALSY, ARRHYTHMIAS, CARDIAC TAMPONADE, ANEURYSM, ALLERGIC REACTION, POSTOPERATIVE COMPLICATIONS, PNEUMOTHORAX, ATRIOVENTRICULAR BLOCK, SHOCK, HEMOLYSIS, DETACHMENT, SUDDEN DEATH, ADVERSE EVENTS, HEART FAILURE, HEMATOMA, HEMOTHORAX, ATRIAL FIBRILLATION, INFECTION
The PFO closure surgery is a well-established interventional procedure with possible postoperative complications and serious adverse events, including (1) allergic reactions to anesthetics or contrast media. (2) High vagal response. (3) Major bleeding, hematoma, vascular dissection rupture, aneurysm, and arteriovenous fistula leading to mechanical hemolysis. (4) Severe arrhythmias such as atrial fibrillation. (5) Embolization. (6) Thrombocytopenia and severe platelet input. (7) Displacement or detachment of closure device material. (8) Catheter knotting, breakage, or injury. (9) Atrioventricular block. (10) Infection. 11. Hemothorax and pneumothorax. 12. Shock. 13. Cardiac tamponade. 14. Sudden death. 15. Heart failure. 16. Phrenic nerve palsy. 17. Arterial dissection, among others.