Model Number H7493942820500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
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Event Date 05/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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(b)(6) post market study: it was reported that myocardial infarction and stent thrombosis occurred.On (b)(6) 2021 and prior to procedure, the subject was found to have indication for myocardial infarction (mi) and the index procedure was performed on the same day.The 80% stenosed target lesion was located in the mid left anterior descending artery (lad).The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.One day post procedure, cardiac enzymes were noted to be elevated.Left heart catheterization was performed and the subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, left heart catheterization with percutaneous coronary intervention (pci) was performed and medications were administered.On (b)(6) 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.
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Manufacturer Narrative
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A1 patient identifier: (b)(6).
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Event Description
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Evolve lv xlv post market study: it was reported that myocardial infarction and stent thrombosis occurred.On (b)(6) 2021 and prior to procedure, the subject was found to have indication for myocardial infarction (mi) and the index procedure was performed on the same day.The 80% stenosed target lesion was located in the mid left anterior descending artery (lad).The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.One day post procedure, cardiac enzymes were noted to be elevated.Left heart catheterization was performed and the subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, left heart catheterization with percutaneous coronary intervention (pci) was performed and medications were administered.On (b)(6) 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.It was further reported that on (b)(6) 2021, the 80% stenosed target lesion was located in the mid lad and was 20mm long, with a reference vessel diameter of 5mm.The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.It was noted that the megatron was deployed at a pressure of 20mm.Following post dilatation, residual stenosis was 0%.The stent was post dilated using a 6mm balloon, with a maximum pressure of 18mm.It was noted that intravascular ultrasound (ivus) was performed during the procedure.On (b)(6), the subject was diagnosed with stemi (st segment elevation myocardial infarction) and was referred for selective coronary angiogram.The 99% subtotal, thrombosed, ulcerated occlusion was located in the mid to distal lad.The subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, medications were administered.The 99% mid lad was treated with a predilation and placement of a 4.50 x 16mm synergy xd mr stent.Following post dilation, residual stenosis was 0%.On the same day, the 100% stenosed distal lad was treated with predilation and placement of a 4.00 x 20.0mm synergy xd mr stent.Following post dilation, residual stenosis was 0%.On 03 may 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.On (b)(6) 2021, the subject was started on a medication, prasugrel.
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Manufacturer Narrative
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A1 patient identifier: (b)(6).
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Event Description
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Evolve lv xlv post market study.It was reported that myocardial infarction and stent thrombosis occurred.On (b)(6) 2021 and prior to procedure, the subject was found to have indication for myocardial infarction (mi) and the index procedure was performed on the same day.The 80% stenosed target lesion was located in the mid left anterior descending artery (lad).The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.One day post procedure, cardiac enzymes were noted to be elevated.Left heart catheterization was performed and the subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, left heart catheterization with percutaneous coronary intervention (pci) was performed and medications were administered.On (b)(6) 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.It was further reported that on (b)(6) 2021, the 80% stenosed target lesion was located in the mid lad and was 20mm long, with a reference vessel diameter of 5mm.The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.It was noted that the megatron was deployed at a pressure of 20mm.Following post dilatation, residual stenosis was 0%.The stent was post dilated using a 6mm balloon, with a maximum pressure of 18mm.It was noted that intravascular ultrasound (ivus) was performed during the procedure.On (b)(6) 2021, the subject was diagnosed with stemi (st segment elevation myocardial infarction) and was referred for selective coronary angiogram.The 99% subtotal, thrombosed, ulcerated occlusion was located in the mid to distal lad.The subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, medications were administered.The 99% mid lad was treated with a predilation and placement of a 4.50 x 16mm synergy xd mr stent.Following post dilation, residual stenosis was 0%.On the same day, the 100% stenosed distal lad was treated with predilation and placement of a 4.00 x 20.0mm synergy xd mr stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.On (b)(6) 2021, the subject was started on a medication, prasugrel.It was further reported that on (b)(6) 2021, cardiac enzyme (troponin i) was found to be elevated.An ekg performed revealed sinus tachycardia with st elevation consider anterolateral injury or acute infarct and significant changes were not from previous ekg.The subject was discharged on aspirin, eliquis, and prasugrel.
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Manufacturer Narrative
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A1 patient identifier:(b)(6).
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Event Description
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Evolve lv xlv post market study.It was reported that myocardial infarction and stent thrombosis occurred.On (b)(6) 2021 and prior to procedure, the subject was found to have indication for myocardial infarction (mi) and the index procedure was performed on the same day.The 80% stenosed target lesion was located in the mid left anterior descending artery (lad).The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.One day post procedure, cardiac enzymes were noted to be elevated.Left heart catheterization was performed and the subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, left heart catheterization with percutaneous coronary intervention (pci) was performed and medications were administered.On (b)(6) 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.It was further reported that on (b)(6) 2021, the 80% stenosed target lesion was located in the mid lad and was 20mm long, with a reference vessel diameter of 5mm.The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.It was noted that the megatron was deployed at a pressure of 20mm.Following post dilatation, residual stenosis was 0%.The stent was post dilated using a 6mm balloon, with a maximum pressure of 18mm.It was noted that intravascular ultrasound (ivus) was performed during the procedure.On (b)(6) 2021, the subject was diagnosed with stemi (st segment elevation myocardial infarction) and was referred for selective coronary angiogram.The 99% subtotal, thrombosed, ulcerated occlusion was located in the mid to distal lad.The subject was diagnosed with stent thrombosis.Myocardial infarction (mi) was diagnosed based on symptoms suggestive of mi with the location of mi to be anterior (septal).The mi noted was not a q wave mi.In response to the event, medications were administered.The 99% mid lad was treated with a predilation and placement of a 4.50 x 16mm synergy xd mr stent.Following post dilation, residual stenosis was 0%.On the same day, the 100% stenosed distal lad was treated with predilation and placement of a 4.00 x 20.0mm synergy xd mr stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2021, the event was considered to be recovering and resolved, and the subject was discharged on the same day.On (b)(6) 2021, the subject was started on a medication, prasugrel.It was further reported that on (b)(6) 2021, cardiac enzyme (troponin i) was found to be elevated.An ekg performed revealed sinus tachycardia with st elevation consider anterolateral injury or acute infarct and significant changes were not from previous ekg.The subject was discharged on aspirin, eliquis, and prasugrel.It was further reported that on (b)(6) 2021, left heart catheterization revealed 80% thrombotic stenosis in the mid lad.On (b)(6) 2021, the subject was enrolled in the megatron cohort of the evolve lv xlv study and the index procedure was performed on the same day.The 80% stenosed target lesion was located in the mid lad and was 20mm long, with a reference vessel diameter of 5mm.The lesion was treated with predilatation and placement of a 5.00 x 20mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2021, one day post index procedure, the subject experienced sharp, mid sternal progressively worsening chest pain.The subject was unable to sit still and was slightly shaking at times.Hence, sublingual nitroglycerine was administered and in addition, morphine was given as sublingual nitroglycerine did not alleviate the pain.An additional physical examination revealed that the subject was tachycardiac with a pulse of 93 beats per minute (bpm).On the same day, an ekg was performed and revealed sinus tachycardia with worsening st elevations v2, v3, v4, and v5.St depressions in lead iii and avf suggesting anterolateral injury or acute infarct and significant changes were noted from previous ekg.Cardiac enzymes (troponin i) was found to be elevated, consistent with protocol definition of peri procedural mi (peak troponin i: 39.28 ng/ml (uln: 0.05 ng/ml) and peak ck total: 282 iu/l (uln: 267 iu/l).Of note, baseline pre procedural cardiac enzymes performed on (b)(6) 2021 at 22:37 revealed troponin i value to be 0.17 ng/ml (uln: 0.05 ng/ml) and ck total: 855 iu/l (uln: 267 iu/l) and baseline pre procedural cardiac enzymes performed on (b)(6) 2021 at 05:49 revealed: troponin i value to be 3.13 ng/ml (uln: 0.05 ng/ml) and ck total: 1097 iu/l (uln: 267 iu/l).The mi was diagnosed based on symptoms, biomarker elevation and ecg changes with location of mi to be anterior (septal).The mi noted was not a q wave mi.On (b)(6) 2021, selective coronary angiogram was performed which revealed a 99% stenosed subtotal, thrombosed, ulcerated occlusion in the mid to distal lad and a 10% stenosis in the distal lad.The 99% stenosis in the mid lad (cass site# 13) to distal lad (cass site # 14) was treated with predilation and subsequent deployment of a 4.50 x 16mm synergy xd mr stent.Following post dilation, residual stenosis was 0% with timi flow 3.Additionally on the same day, the 100% stenosis in the distal lad (cass site #14) was treated with pre dilation and subsequent placement of a 4.00 x 20.0mm synergy xd mr stent.Following post dilation, residual stenosis was 0% with timi flow 3.On (b)(6) 2021, physical examination revealed regular cardiovascular rate and normal sinus rhythm with pulse 60 to 80s and non sustained ventricular tachycardia.On the same day, the event was considered recovering and resolving and the subject was discharged on the same day on aspirin, eliquis and prasugrel.It was further reported that on (b)(6) 2021, left ventricular end diastolic pressure was 8mmhg.Low normal lv systolic function with normal wall motion.Estimated ejection fraction was 50 to 55%.Very mild basilar anterior hypokinesis, antero basal wall was hypokinetic with all other visualized walls were normal.Coronary artery disease with one vessel disease.On (b)(6) 2021, the subject described chest pain as sharp, mid sternal progressively worsening along with symptoms of right arm pain and a baseline shortness of breath.Of note, two months ago the subject was tested positive covid 19 without any complications.However, the subject was yet to be vaccinated.Subjects current condition with regards to covid 19 is unknown.
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