Model Number 10622 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Arteriosclerosis/ Atherosclerosis (4437)
|
Event Date 01/17/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.In (b)(6) 2020, 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 proximal right coronary artery (rca) extending up to middle rca with 99% stenosis and was 54 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 32 mm overlapped on to 3.50 mm x 28 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.In (b)(6) 2020, staged procedure was performed and the target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to middle lad with 90% stenosis and was 66 mm long with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 32 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.The target lesion 2 was located in the distal right coronary artery (rca) extending up to middle rca with 95% stenosis and was 46 mm long with a reference vessel diameter of 2.75 mm.The target lesion 2 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 12 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with a coronary atherosclerotic heart disease and was hospitalized on same day for further treatment.Angiography without revascularization was performed.No other action was taken to treat the event.Three days later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.
|
|
Manufacturer Narrative
|
E1 - initial reporter facility name: (b)(6).
|
|
Event Description
|
Synergy china registry.It was reported that coronary atherosclerotic heart disease occurred.In october 2020, 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 proximal right coronary artery (rca) extending up to middle rca with 99% stenosis and was 54 mm long with a reference vessel diameter of 3.5 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 32 mm overlapped on to 3.50 mm x 28 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.In (b)(6) 2020, staged procedure was performed and the target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to middle lad with 90% stenosis and was 66 mm long with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 32 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.The target lesion 2 was located in the distal right coronary artery (rca) extending up to middle rca with 95% stenosis and was 46 mm long with a reference vessel diameter of 2.75 mm.The target lesion 2 was treated with pre-dilatation and placement of a 2.50 mm x 38 mm overlapped on to 2.75 mm x 12 mm synergy stent systems.Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In january 2022, the subject was diagnosed with a coronary atherosclerotic heart disease and was hospitalized on same day for further treatment.Angiography without revascularization was performed.No other action was taken to treat the event.Three days later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.It was further reported that target lesion 2 was located in the proximal left circumflex (lcx) artery extending first obtuse marginal and not middle rca extending to distal rca as previously reported.
|
|
Search Alerts/Recalls
|
|