Model Number 10619 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
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Event Date 09/08/2020 |
Event Type
Injury
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Event Description
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(b)(6) study.It was reported that cardiac related symptoms and coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the mid left anterior descending artery (lad) extending up to distal lad with 99% stenosis and was 38 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of 3.0 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.After three days, staged procedure was performed.The target lesion #1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 84 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 32 mm, 3.50 mm x 32 mm and 3.50 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Target lesion #2 was located in the mid left circumflex (lcx) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of 3.0 mm x 38 mm synergy stent system.Three days post procedure, the subject was discharged on aspirin and other medications.In (b)(6) 2020, the subject presented with cardiac related symptoms and was hospitalized on the same day for further analysis.Diagnostics revealed coronary atherosclerotic heart disease.Medication was given and non- target vessel revascularization(tvr) was performed to treat the event.The following day, the event was considered recovered/resolved and the subject was discharged.
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Event Description
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Synergy china registry clinical study.It was reported that cardiac related symptoms and coronary atherosclerotic heart disease occurred.In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the mid left anterior descending artery (lad) extending up to distal lad with 99% stenosis and was 38 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of 3.0 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.After three days, staged procedure was performed.The target lesion #1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 84 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 32 mm, 3.50 mm x 32 mm and 3.50 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Target lesion #2 was located in the mid left circumflex (lcx) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of 3.0 mm x 38 mm synergy stent system.Three days post procedure, the patient was discharged on aspirin and other medications.In september 2020, the subject presented with cardiac related symptoms and was hospitalized on the same day for further analysis.Diagnostics revealed coronary atherosclerotic heart disease.Medication was given and non- target vessel revascularization(tvr) was performed to treat the event.The following day, the event was considered recovered/resolved and the subject was discharged.It was further reported that in (b)(6) 2020, the subject was referred for coronary angiography and 70% stenosis was noted in distal rca which had previously placed study device.The event was treated with percutaneous coronary intervention-tvr.Post intervention, residual stenosis was 0%.The event was also treated medically.
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Search Alerts/Recalls
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