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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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| Model Number 6534 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Myocardial Infarction (1969); Vasoconstriction (2126); Restenosis (4576)
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| Event Date 07/08/2021 |
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Event Type
Injury
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Event Description
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It was reported that myocardial infarction occurred.In (b)(6) 2021, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.Heparin or antithrombotic medication gp iib/iiia inhibitor were administered at the time of index procedure.The subject was on a prior regimen of aspirin (>= 72 hours) at the time of index procedure and loading dose of 300 mg of clopidogrel was given prior to the procedure.The target lesion 1 was located at the mid left anterior descending (lad) artery and was 24 mm long with a reference vessel diameter was 3.00 mm.The target lesion was predilated with 3.00 mm x 30 mm balloon with 30% residual stenosis.Following pre-dilation, the lesion was treated with 3.00 mm x 30 mm nc quantum apex plain old balloon angioplasty (poba) successfully with 30% residual stenosis.Post-dilation was not performed.The baseline cardiac enzymes were as follows: ck-mb: 2.6 ng/ml (reference range: 7.7 ng/ml).Troponin t: 0.199 ng/ml (reference range: 22 ng/ml).On the following day, elevation of ck-mb was noted consistent with protocol definition of myocardial infarction.Peak ck-mb: 113.2 ng/ml (reference range: 7.7 ng/ml).Electrocardiogram (ecg) was performed on the same day; however, ecg results are currently not available.The subject was diagnosed with myocardial infarction (mi) and the event led to prolongation of hospitalization.Per electronic data capture (edc), the rationale for diagnosis was symptoms and biomarker elevation.The location of myocardial infarction was not identifiable and was not q wave mi.Coronary angioplasty with agent balloon (crossover) was performed and medication was given to treat the event.Five days later, the subject was discharged.At the time of reporting, the event was ongoing.
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Event Description
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It was reported that myocardial infarction occurred.In (b)(6) 2021, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.Heparin or antithrombotic medication gp iib/iiia inhibitor were administered at the time of index procedure.The subject was on a prior regimen of aspirin (>= 72 hours) at the time of index procedure and loading dose of 300 mg of clopidogrel was given prior to the procedure.The target lesion 1 was located at the mid left anterior descending (lad) artery and was 24 mm long with a reference vessel diameter was 3.00 mm.The target lesion was predilated with 3.00 mm x 30 mm balloon with 30% residual stenosis.Following pre-dilation, the lesion was treated with 3.00 mm x 30 mm nc quantum apex plain old balloon angioplasty (poba) successfully with 30% residual stenosis.Post-dilation was not performed.The baseline cardiac enzymes were as follows: ck-mb: 2.6 ng/ml (reference range: 7.7 ng/ml).Troponin t: 0.199 ng/ml (reference range: 22 ng/ml).On the following day, elevation of ck-mb was noted consistent with protocol definition of myocardial infarction.Peak ck-mb: 113.2 ng/ml (reference range: 7.7 ng/ml).Electrocardiogram (ecg) was performed on the same day; however, ecg results are currently not available.The subject was diagnosed with myocardial infarction (mi) and the event led to prolongation of hospitalization.Per electronic data capture (edc), the rationale for diagnosis was symptoms and biomarker elevation.The location of myocardial infarction was not identifiable and was not q wave mi.Coronary angioplasty with agent balloon (crossover) was performed and medication was given to treat the event.Five days later, the subject was discharged.At the time of reporting, the event was ongoing.It was further reported that one day post index procedure, the subject was noted with chest pain.The ecg revealed st & t wave abnormality, prolonged qt and t wave inversion evident in anterolateral leads, indicating anterolateral ischemia.On the following day, ecg revealed inverted t waves that replaced nonspecific t wave abnormality in inferior leads.The event was treated medically.However, the subject had repeated episodes of angina, hence the decision for revascularization was made.The antiplatelet medication during the hospitalization was unknown.Three days later (5-days post index procedure), coronary angiography revealed 90% in-stent restenosis at the mid lad -1 (target) lesion and 50% in-stent stenosis at mid lad- 2 (target) lesion with 90% stenosed side branch in 2nd diagonal.Distal lad was 70% stenosed and lcx was 100% stenosis at the 1st obtuse marginal.On the same day, pre-dilation was performed using multiple balloon inflations in the mid to distal lad, using emerge 3.0 x 20 mm balloon.Post inflation, 2nd diagonal branch had slow flow, which was probably due to spasm as balloon inflation was performed distal to the bifurcation.A non-boston scientific (bsc) guide wire was then placed into the 2nd diagonal and sequential balloon dilation was performed with emerge and non-bsc balloon catheter to treat the lesions.Percutaneous coronary angioplasty with agent balloon (crossover) was also performed to treat 90% stenosis mid lad and distal lad.Post revascularization 10% residual stenosis with timi flow 3 was noted.The 2nd diagonal with 90% stenosis was also revascularized using balloon angioplasty.Post revascularization 40% residual stenosis with timi flow 3 was noted.The following day the event was considered to be recovered/resolved and the subject was discharged on the same day.
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Event Description
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Agent ide clinical study it was reported that myocardial infarction occurred.In (b)(6) 2021, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.Heparin or antithrombotic medication gp iib/iiia inhibitor were administered at the time of index procedure.The subject was on a prior regimen of aspirin (>= 72 hours) at the time of index procedure and loading dose of 300 mg of clopidogrel was given prior to the procedure.The target lesion 1 was located at the mid left anterior descending (lad) artery and was 24 mm long with a reference vessel diameter was 3.00 mm.The target lesion was predilated with 3.00 mm x 30 mm balloon with 30% residual stenosis.Following pre-dilation, the lesion was treated with 3.00 mm x 30 mm nc quantum apex plain old balloon angioplasty (poba) successfully with 30% residual stenosis.Post-dilation was not performed.The baseline cardiac enzymes were as follows: ck-mb: 2.6 ng/ml (reference range: 7.7 ng/ml).Troponin t: 0.199 ng/ml (reference range: 22 ng/ml).On the following day, elevation of ck-mb was noted consistent with protocol definition of myocardial infarction.Peak ck-mb: 113.2 ng/ml (reference range: 7.7 ng/ml).Electrocardiogram (ecg) was performed on the same day; however, ecg results are currently not available.The subject was diagnosed with myocardial infarction (mi) and the event led to prolongation of hospitalization.Per electronic data capture (edc), the rationale for diagnosis was symptoms and biomarker elevation.The location of myocardial infarction was not identifiable and was not q wave mi.Coronary angioplasty with agent balloon (crossover) was performed and medication was given to treat the event.Five days later, the subject was discharged.At the time of reporting, the event was ongoing.It was further reported that one day post index procedure, the subject was noted with chest pain.The ecg revealed st & t wave abnormality, prolonged qt and t wave inversion evident in anterolateral leads, indicating anterolateral ischemia.On the following day, ecg revealed inverted t waves that replaced nonspecific t wave abnormality in inferior leads.The event was treated medically.However, the subject had repeated episodes of angina, hence the decision for revascularization was made.The antiplatelet medication during the hospitalization was unknown.Three days later (5-days post index procedure), coronary angiography revealed 90% in-stent restenosis at the mid lad -1 (target) lesion and 50% in-stent stenosis at mid lad- 2 (target) lesion with 90% stenosed side branch in 2nd diagonal.Distal lad was 70% stenosed and lcx was 100% stenosis at the 1st obtuse marginal.On the same day, pre-dilation was performed using multiple balloon inflations in the mid to distal lad, using emerge 3.0 x 20 mm balloon.Post inflation, 2nd diagonal branch had slow flow, which was probably due to spasm as balloon inflation was performed distal to the bifurcation.A non-boston scientific (bsc) guide wire was then placed into the 2nd diagonal and sequential balloon dilation was performed with emerge and non-bsc balloon catheter to treat the lesions.Percutaneous coronary angioplasty with agent balloon (crossover) was also performed to treat 90% stenosis mid lad and distal lad.Post revascularization 10% residual stenosis with timi flow 3 was noted.The 2nd diagonal with 90% stenosis was also revascularized using balloon angioplasty.Post revascularization 40% residual stenosis with timi flow 3 was noted.The following day the event was considered to be recovered/resolved and the subject was discharged on the same day.It was further reported that in (b)(6) 2021, the subject was diagnosed with non-st elevation myocardial infarction.The baseline ecg revealed sinus rhythm with t wave abnormality, lateral ischemia with st depression in the anterior lead.During the index procedure, a non-bsc guide wire was placed in the native distal lad artery.The target lesion was predilated with multiple balloon inflations.Following pre-dilation, final balloon angioplasty was performed using 3.00 mm x 30 mm nc quantum apex (poba).Post balloon dilation, final angiographic results revealed better expansion of the previously placed stents in the mid lad artery with distal spasm in lad and was treated with nitroglycerin.The event was considered to be recovered and resolved on the same day.One day post index procedure, the subject was noted with persistent exertional chest pain and nitroglycerin 10 mcg/min was given.Nitroglycerin was increased to 20 mcg/min, anti-anginal medication dosing was increased, and amlodipine 2.5 mg was added to medically manage the recurring angina.Two days post index procedure, ecg revealed inverted t waves that replaced nonspecific t wave abnormality in inferior leads and 1st degree atrioventricular (av) block.Even though medications were adjusted, the subject continued to have repeated episodes of angina hence the decision for revascularization was made.Five days post index procedure, an ecg revealed st and t wave abnormality and anterolateal ischemia.Additionally, diagnostic angiography revealed right coronary artery (rca) 100% occlusion and patent (right ventricle) rv marginal branch with collaterization of the obtuse marginal (om)/left system.The saphenous vein graft to the r-pda(right posterior descending artery) was patent.The left internal mammary artery (lima) to the lad had multiple stents with recurrent in-stent restenosis and evidence of recoil.The first stented region of the mid lad (target lesion) was 50% stenosed with adjacent 90% stenotic lesion in the ostial second diagonal branch.The second stented region of the mid lad (target lesion) was 90% stenosed.The distal lad was 70% stenosed.There was 100% stenosis at the 1st om.Multiple balloon inflations were then performed using emerge 3.0 x 20 mm balloon from mid to distal lad.Post inflation, the 2nd diagonal branch had slow flow, which was probably due to spasm as balloon inflation was performed distal to the bifurcation.Intracoronary nitroglycerine was administered.A non-bsc guide wire was then placed into the 2nd diagonal branch and 90% stenosis was treated with sequential balloon dilations performed at the diagonal ostium with a non-bsc balloon.Following this, simultaneous kissing balloon angioplasty was performed at 2nd diagonal using 3 mm emerge balloon and 2 mm non-bsc balloon.Post revascularization of 2nd diagonal, 40% residual stenosis with timi flow 3 was noted.Percutaneous coronary angioplasty with a 3.0 x 30 mm agent drug coated balloon (crossover) was performed to treat the 90% in-stent restenosis at mid lad and distal lad (target vessel revascularization (tvr).Post revascularization of mid lad and distal lad, 10% residual stenosis with timi flow 3 was noted.The following day, nitroglycerin was weaned off and the subject was ambulating without any chest pain.The event was considered to be recovered and resolved and the subject was discharged home in stable condition on aspirin and clopidogrel.
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