It was reported that stent thrombosis and death occurred.In 2016, and unspecified synergy drug-eluting stent was implanted to treat a target lesion in the left anterior descending artery (lad).In (b)(6) 2019, the patient presented with thrombus occlusion around the synergy stent.Percutaneous coronary intervention (pci) was performed and a 2.50 x 16 synergy drug-eluting stent was placed, however, flow became worse and the patient was placed on intra-aortic balloon pump support.The next day, urgent coronary angiography was performed which revealed thrombus occlusion after the treated segment.After pci was performed, thrombus aspiration, pulse infusion thrombolysis and reperfusion/reflushing were also performed.The hemodynamics got worse so percutaneous cardiopulmonary support was inserted.As a result, the left ventricle ruptured and the patient passed away the next day.
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It was reported that stent thrombosis and death occurred.In 2016, an unspecified synergy drug-eluting stent was implanted to treat a target lesion in the left anterior descending artery (lad).In november 2019, the patient presented with thrombus occlusion around the synergy stent.Percutaneous coronary intervention (pci) was performed and a 2.50 x 16 synergy drug-eluting stent was placed, however, flow became worse and the patient was placed on intra-aortic balloon pump support.The next day, urgent coronary angiography was performed which revealed thrombus occlusion after the treated segment.After pci was performed, thrombus aspiration, pulse infusion thrombolysis and reperfusion/reflushing were also performed.The hemodynamics got worse so percutaneous cardiopulmonary support was inserted.As a result, the left ventricle ruptured and the patient passed away the next day.It was further reported that the patient had taken 75mg clopidogrel since january 2010.Along with the thrombus suction, dilatation was performed with a balloon catheter, an intra-aortic balloon pump (iabp) was inserted, and aspirin administration was started.Two days later, suction was attempted for the re-thrombus occlusion, however the left ventricle perforation occurred and the patient died.The physician considered patient condition to have caused the stent thrombosis and that there was no causal correlation between this device and the stent thrombosis and death.
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