Model Number 10620 |
Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atherosclerosis (1728); Reocclusion (1985); Thrombosis (2100); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
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Event Date 08/10/2020 |
Event Type
Injury
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Event Description
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(b)(6) registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary rtery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% stenosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.
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Event Description
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Synergy china registry it was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary artery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% stenosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.It was further reported that balloon dilatation was performed in the rca and left posterior descending artery which qualifies for target vessel revascularization (tvr) and non-tvr.
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Event Description
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Synergy china registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary rtery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% thrombosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.It was further reported that balloon dilatation was performed in the rca and left posterior descending artery which qualifies for target vessel revascularization (tvr) and non-tvr.It was further reported that the index procedure target lesion was located in the proximal rca extending to the distal rca.Additionally, in (b)(6) 2020, coronary angiography revealed 70% stenosis in proximal rca extending to mid rca was treated with percutaneous coronary intervention (pci).The event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was withdrawn.
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Event Description
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Synergy china registry.It was reported that stent thrombosis occurred.In (b)(6) 2019, the subject was enrolled and the index procedure was performed on same day.The target lesion was located in the mid right coronary rtery (rca) extending up to distal rca with 100% stenosis and was 93 mm long, with a reference vessel diameter of 4 mm.The target lesion was treated with pre-dilatation and placement of 4.00 mm x 24 mm synergy stent, overlapped with two 3.50 mm x 38 mm and 3.50 mm x 38 mm synergy stents.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease, stent thrombosis, and was hospitalized on the same day for further evaluation and treatment.On the following day, coronary angiography was performed which revealed 70% thrombosis in mid rca.Balloon dilatation was performed to treat the event.The event was considered to be recovering/resolving and the subject was discharged on the next day.It was further reported that balloon dilatation was performed in the rca and left posterior descending artery which qualifies for target vessel revascularization (tvr) and non-tvr.It was further reported that the index procedure target lesion was located in the proximal rca extending to the distal rca.Additionally, in (b)(6) 2020, coronary angiography revealed 70% stenosis in proximal rca extending to mid rca was treated with percutaneous coronary intervention (pci).The event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was withdrawn.It was further reported that at the time of the pci in (b)(6) 2020, the patient was asymptomatic with no signs of ischemia.
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Search Alerts/Recalls
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