| Model Number 10621 |
| Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Cardiac Arrest (1762); Chest Pain (1776); Fever (1858); Ischemia (1942); Myocardial Infarction (1969); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/02/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (b)(6).Initial reporter facility name: (b)(6).
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Event Description
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(b)(6) clinical study.It was reported that the patient died.In (b)(6)2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the (b)(6) study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.
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Event Description
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Evolve_lv_xlv clinical study.It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary caused of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.
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Manufacturer Narrative
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A1- patient identifier: (b)(6).E1-initial reporter facility name: (b)(6).
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Manufacturer Narrative
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H6: patient codes: no clinical signs, symptoms or conditions (e2403) previously reported and now been updated to cardiac arrest (e0602) and myocardial infarction (e061202) h6: impact codes: no health consequences (f26) previously reported and now been updated to serious injury/illness/impairment (f12).A1: -patient identifier: (b)(6).E1: initial reporter facility name: (b)(6).
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Event Description
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Evolve_lv_xlv clinical study.It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed, and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary cause of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that primary cause of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest, and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery(rpl) had a large burden of clot and svg-pda is chronically occluded.Furthermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021 and (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.Chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range:11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired, and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.
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Event Description
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Evolve_lv_xlv clinical study.It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed, and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary cause of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest, and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: <= 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery(rpl) had a large burden of clot and svg-pda is chronically occluded.Futhermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: <= 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: <= 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.-chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range: <= 11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired, and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.It was further reported that the event was classified as stent thrombosis.Furthermore, in lad- chronic total occlusion in proximal segment right after its take off from lmca.Subject was found to have large clot burden to distal rca, proximal pda, proximal rpl which was considered as cause of st elevation of myocardial infarction.Hence, subject underwent aspirational thrombectomy to treat distal rca to proximal pda and angioplasty to treat ostial rpl/proximal rpl.
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Manufacturer Narrative
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H6-patient code thrombosis has been added.H6-device code updated.B5 - describe event or problem has been updated b2 - outcomes attrib to adv event has been updated h6 - patient codes: no clinical signs, symptoms or conditions (e2403) previously reported and now been updated to cardiac arrest (e0602) and myocardial infarction (e061202) h6 - impact codes: no health consequences (f26) previously reported and now been updated to serious injury/illness/impairment (f12).A1- patient identifier: (b)(6).E1-initial reporter facility name: (b)(6).
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Event Description
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Same case as pr id# (b)(4).Evolve_lv_xlv clinical study.It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary caused of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: <= 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery (rpl) had a large burden of clot and svg-pda is chronically occluded.Futhermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: <= 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: <= 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021 and (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.-chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range: <= 11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.It was further reported that the event was classified as stent thrombosis.Furthermore, in lad- chronic total occlusion in proximal segment right after its take off from lmca.Subject was found to have large clot burden to distal rca, proximal pda, proximal rpl which was considered as cause of st elevation of myocardial infarction.Hence, subject underwent aspirational thrombectomy to treat distal rca to proximal pda and angioplasty to treat ostial rpl/proximal rpl.It was further reported that in (b)(6) 2019, pre procedural angiography performed revealed failure of all bypass grafts, complete total occlusion of lad, obstructive disease in the circumflex extending back into the left main coronary artery, significant disease in the proximal rca and known chronic total occlusion of rpda.
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Manufacturer Narrative
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A1: patient identifier: (b)(6).E1: initial reporter facility name: (b)(6).
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Event Description
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Same case as pr id# (b)(4).Evolve_lv_xlv clinical study.It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that that primary caused of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: <= 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery(rpl) had a large burden of clot and svg-pda is chronically occluded.Futhermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: <= 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: <= 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.-chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range: <= 11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.It was further reported that the event was classified as stent thrombosis.Furthermore, in lad- chronic total occlusion in proximal segment right after its take off from lmca.Subject was found to have large clot burden to distal rca, proximal pda, proximal rpl which was considered as cause of st elevation of myocardial infarction.Hence, subject underwent aspirational thrombectomy to treat distal rca to proximal pda and angioplasty to treat ostial rpl/proximal rpl.It was further reported that in (b)(6) 2019, pre-procedural angiography performed revealed failure of all bypass grafts, complete total occlusion of lad, obstructive disease in the circumflex extending back into the left main coronary artery, significant disease in the proximal rca and known chronic total occlusion of rpda.It was further reported that balloon dilatation was performed in the distal rca to which qualifies for target vessel revascularization (tvr).Furthermore, it was noted that the upper limit normal was captured as 99 ng/ml based on the protocol uln reference range.Mi was diagnosed based on ecg changes with location of mi to be posterior.Its unknown whether mi is a q wave mi.Also, mi was diagnosed based on biomarker elevation and ecg changes and its unknown if mi noted was a q wave mi.It was further reported that the patient died due to stemi as it led to code and not in anoxic brain injury as previously reported.
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Manufacturer Narrative
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H6-impact code death has been added.B5-describe event or problem has been updated b6-relevant tests/laboratory data has been updated h6-patient codes: restenosis (e233701) has been added.A1- patient identifier: (b)(6).E1-initial reporter facility name: (b)(6).
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Event Description
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Same case as pr id# (b)(4).(b)(6).It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In march 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary caused of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: <= 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery(rpl) had a large burden of clot and svg-pda is chronically occluded.Futhermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: <= 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: <= 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021 and (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.-chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range: <= 11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.It was further reported that the event was classified as stent thrombosis.Furthermore, in lad- chronic total occlusion in proximal segment right after its take off from lmca.Subject was found to have large clot burden to distal rca, proximal pda, proximal rpl which was considered as cause of st elevation of myocardial infarction.Hence, subject underwent aspirational thrombectomy to treat distal rca to proximal pda and angioplasty to treat ostial rpl/proximal rpl.It was further reported that in (b)(6) 2019, pre procedural angiography performed revealed failure of all bypass grafts, complete total occlusion of lad, obstructive disease in the circumflex extending back into the left main coronary artery, significant disease in the proximal rca and known chronic total occlusion of rpda.It was further reported that balloon dilatation was performed in the distal rca to which qualifies for target vessel revascularization (tvr).Furthermore, it was noted that the upper limit normal was captured as 99 ng/ml based on the protocol uln reference range.Mi was diagnosed based on ecg changes with location of mi to be posterior.Its unknown whether mi is a q wave mi.Also, mi was diagnosed based on biomarker elevation and ecg changes and its unknown if mi noted was a q wave mi.
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Manufacturer Narrative
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B5-describe event or problem has been updated.B6-relevant tests/laboratory data has been updated.H6-patient codes: restenosis (e233701) has been added.----------------------------------------------------------------------------------------- a1- patient identifier: (b)(6).E1-initial reporter facility name: (b)(6).
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Manufacturer Narrative
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H6 patient codes has been added: respiratory failure (e0742), fever (e230101, ischemia (e0509), chest pain (e233001).H6 impact codes has been added: medication required (f2303), hospitalization or prolonged hospitalization (f08).H6-impact code death has been added.B5-describe event or problem has been updated, b6-relevant tests/laboratory data has been updated, h6-patient codes: restenosis (e233701) has been added.A1- patient identifier: (b)(6).E1-initial reporter facility name: (b)(6).
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Event Description
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Same case as pr id# (b)(4).Evolve_lv_xlv clinical study.It was reported that the patient died.In (b)(6) 2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary caused of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery(rpl) had a large burden of clot and svg-pda is chronically occluded.Futhermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021 and (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.-chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range: 11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.It was further reported that the event was classified as stent thrombosis.Furthermore, in lad- chronic total occlusion in proximal segment right after its take off from lmca.Subject was found to have large clot burden to distal rca, proximal pda, proximal rpl which was considered as cause of st elevation of myocardial infarction.Hence, subject underwent aspirational thrombectomy to treat distal rca to proximal pda and angioplasty to treat ostial rpl/proximal rpl.It was further reported that in october 2019, pre procedural angiography performed revealed failure of all bypass grafts, complete total occlusion of lad, obstructive disease in the circumflex extending back into the left main coronary artery, significant disease in the proximal rca and known chronic total occlusion of rpda.It was further reported that balloon dilatation was performed in the distal rca to which qualifies for target vessel revascularization (tvr).Furthermore, it was noted that the upper limit normal was captured as 99 ng/ml based on the protocol uln reference range.Mi was diagnosed based on ecg changes with location of mi to be posterior.Its unknown whether mi is a q wave mi.Also, mi was diagnosed based on biomarker elevation and ecg changes and its unknown if mi noted was a q wave mi.It was further reported that the patient died due to stemi as it led to code and not in anoxic brain injury as previously reported.It was further reported that in (b)(6) 2021 before the subject death on (b)(6) 2021, the subject complaints of worsening shortness of breath and fever from past one day.It was noted that the subject denied nausea, vomiting, chest pain, lower extremity edema and on nonrebreather mask with oxygen saturation of 93%.On the same day, subject was admitted for further management of acute hypoxic respiratory failure secondary to covid pneumonia and was treated with the following medications: remdesivir, rocephin, azithromycin, dexamethasone and dapt was held until the month of (b)(6) 2022 due to hematuria.Following day, the subject was also tested positive for covid-19 sars cov2 rna.In addition, valve study revealed a gradient of 30 mmhg across aortic valve concerning for low flow low gradient aortic stenosis.It was also noted that magnetic resonance imaging (mri)as unable to performed because of the subject metal penile pump.The subject chest x-ray has been performed and revealed an increase in consolidation throughout both lungs suggestive of progression of covid to ards and increase pulmonary vascular congestion.The subject was febrile and was noted with increasing fio2.The subject had nstemi and subsequent atrial fibrillation/atrial flutter with elevated cardiac enzyme with peak troponin t: 1120 ng/l; reference range: 11 ng/l and ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia, hence the subject was on heparin gtt.Five days later, subject creatinine was 2.35 mg/dl which was gradually increasing, fluid balance was 07 liters over the last three days, urine output had dropped over last 24 hours suggestive of aki however, renal ultrasound performed on the same day revealed no abnormality.Hence, continuous renal replacement therapy (crrt) and fluid replacement therapy was started.Subject was also noted with anemia due to long hospitalization with hemoglobin and rbc of 8.6g/dl (reference range: 13.5-17.0 g/dl) and 2.85 m/mm3 respectively and malnutrition with albumin 2.7 g/dl (reference range: 3.4-4.9 g/dl).Also, tracheostomy was performed after prolonged intubation as the subject was unable to wean from ventilator.The subject eeg performed revealed intermittent left temporal slowing suggestive of focal cerebral dysfunction and the degree of background slowing suggestive of mild encephalopathy of nonspecific etiology.The subject was kept on amiodarone drip due to atrial flutter and concern for demand ischemia.
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Manufacturer Narrative
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B5-describe event or problem has been updated h6 patient codes has been added: respiratory failure (e0742), fever (e230101, ischemia (e0509), chest pain (e233001).H6 impact codes has been added: medication required (f2303).Hospitalization or prolonged hospitalization (f08).H6-impact code death has been added.B5-describe event or problem has been updated b6-relevant tests/laboratory data has been updated h6-patient codes: restenosis (e233701) has been added.A1- patient identifier: (b)(6).E1-initial reporter facility name: (b)(6).
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Event Description
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Same case as pr id# (b)(4).Evolve_lv_xlv clinical study.It was reported that the patient died.In october 2019, the subject index procedure was performed and qualifying condition was unstable angina and was referred for cardiac catheterization.The subject was enrolled in the 4.5/5.0 cohort of the evolve lv xlv study.Target lesion 1 was located in proximal right coronary artery (rca) with 80% stenosis and was 24 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.Additionally, non-target lesion was also treated.The non-target lesion 1 was located in right-posterior descending artery (r-pda) was treated with placement of 3.00 mm x 28 mm and 2.25 mm x 32 mm synergy stents.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired.The cause of death was unknown, and no action was taken in response to the event.It is unknown whether autopsy was performed or not.It was further reported that primary caused of death was anoxic brain injury.Furthermore, it was reported that the physician considered the death as not related to the device.It was further reported that in (b)(6) 2021, electrocardiogram (ecg) performed revealed, sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality and chest x-ray revealed, widespread patchy airspace disease throughout all lobes with no improvement.In (b)(6) 2021, subject experienced cardiac arrest and delayed return of spontaneous circulation (rosc) was achieved shortly after.Initially, cardiac arrest was assessed as a consequence of hypoxia hence, subject was intubated and transferred to intensive care unit (icu).Subsequently, subject went into atrial fibrillation and ekg/ecg revealed st elevation myocardial infarction (stemi) in inferior leads.Hence, cardiology was consulted and was taken to emergency catheterization.Subject was started on asa, brillinta and heparin gtt.Ecg revealed: sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct.Repeat ecg performed revealed atrial fibrillation, non-specific intraventricular.The cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous myocardial infarction (mi) with peak troponin t: 76 ng/ml; reference range: <= 11 ng/ml).Conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Angiography performed revealed, left main coronary artery (lmca) free of disease, 80-85% stenosis in ostial left circumflex (lcx) and 70-80% focal stenosis in mid om2 and chronically occluded proximal left anterior descending (lad) artery, patent svg-d1 with high grade 90% stenosis at its landing on the diagonal with timi 2 flow downstream.The rca was stented at proximal and ostial segment and in distal rca extending to proximal pda.The proximal pda, the distal rca, the proximal right posterolateral artery(rpl) had a large burden of clot and svg-pda is chronically occluded.Futhermore, the thrombus in distal rca and pda-pla bifurcation was treated with penumbra thrombectomy.Following which, ivus imaging was done which revealed under-expanded stent in distal rca extending to proximal pda, diffuse moderate intensity disease in the mid rca and a well expanded disease with some in-stent restenosis (isr) in the proximal rca.Subsequently, balloon angioplasty was performed using in distal rca to proximal pda stent and ostial to proximal rpl using 3.5 x 20 mm noncompliant balloon and 2.5 mm x 15 mm semi compliant balloon respectively with no residual thrombus.On the following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics and four days later, chest x-ray performed revealed, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Ecg performed revealed, sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.Ct head performed revealed multiple ill-defined hypodensities suggestive of age-indeterminate ischemic changes, loss of cerebral volume, chronic small vessel ischemic changes and prior lacunar infarcts with no acute intracranial hemorrhage, hydrocephalus or herniation.Six days later, sputum culture revealed light growth of klebsiella (enterobacter) aerogenes, light growth proteus mirabilis and light growth of oropharyngeal flora and hence 7-day course of cefepime was started.Ecg revealed sinus rhythm, borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 1154 ng/ml; reference range: <= 11 ng/ml).The subject had non-stemi with subsequent atrial fibrillation/flutter.On the same day, ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia and cardiac enzyme was elevated with peak troponin t: 1120 ng/ml; reference range: <= 11 ng/ml.Repeat ecg revealed: atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.Ecg revealed: atrial flutter, inferior infarct.Cardiac enzyme was found to be elevated with peak troponin t: 1395 ng/ml.Ecg performed revealed: ectopic atrial tachycardia, unifocal left atrial deviation, probable normal variant repolarization abnormality, probable rate related borderline st elevation.On the same day, chest x-ray revealed: widespread patchy airspace disease throughout the lungs with no improvement which were most likely the residual from the covid detected in last month.Amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Chest x-ray revealed: diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.During the course of the hospital stay subject required prbc transfusion on (b)(6) 2021 and (b)(6) 2021, to keep hbg >8.Chest x-ray revealed diffuse airspace opacities in both lungs.Chest x-ray revealed, unchanged bilateral air space disease with no pneumothorax and sizeable effusion.The subject was started on crrt for aki with creatinine: 2.35mg/dl which was gradually increasing from past 5 days.Chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left and chest x-ray performed revealed, persistent moderate cardiomegaly, pulmonary venous hypertension, patchy areas of densities in the airspace may be due to interstitial pulmonary edema or superimposed pneumonia.Ct head/brain performed revealed no acute intracranial abnormalities.Chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.Ecg performed revealed: atrial fibrillation, inferior infarct.-chest x-ray performed revealed, worsening of diffuse bilateral consolidation, worst in right upper lung zone, however no pneumothorax.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin t: 644 ng/ml; reference range: <= 11 ng/ml).Chest x-ray performed revealed, decreased lung volume, no significant change in dense and interstitial diffuse bilateral lung opacities with no significant pleural effusion or pneumothorax.Ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation.The cardiac enzyme was elevated with peak troponin t: 819 ng/ml.In (b)(6) 2021, the subject was expired and the immediate cause of death was event due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.It was further reported that the event was classified as stent thrombosis.Furthermore, in lad- chronic total occlusion in proximal segment right after its take off from lmca.Subject was found to have large clot burden to distal rca, proximal pda, proximal rpl which was considered as cause of st elevation of myocardial infarction.Hence, subject underwent aspirational thrombectomy to treat distal rca to proximal pda and angioplasty to treat ostial rpl/proximal rpl.It was further reported that in (b)(6) 2019, pre procedural angiography performed revealed failure of all bypass grafts, complete total occlusion of lad, obstructive disease in the circumflex extending back into the left main coronary artery, significant disease in the proximal rca and known chronic total occlusion of rpda.It was further reported that balloon dilatation was performed in the distal rca to which qualifies for target vessel revascularization (tvr).Furthermore, it was noted that the upper limit normal was captured as 99 ng/ml based on the protocol uln reference range.Mi was diagnosed based on ecg changes with location of mi to be posterior.Its unknown whether mi is a q wave mi.Also, mi was diagnosed based on biomarker elevation and ecg changes and its unknown if mi noted was a q wave mi.It was further reported that the patient died due to stemi as it led to code and not in anoxic brain injury as previously reported.It was further reported that in january 2021 before the subject death on march 2021, the subject complaints of worsening shortness of breath and fever from past one day.It was noted that the subject denied nausea, vomiting, chest pain, lower extremity edema and on nonrebreather mask with oxygen saturation of 93%.On the same day, subject was admitted for further management of acute hypoxic respiratory failure secondary to covid pneumonia and was treated with the following medications: remdesivir, rocephin, azithromycin, dexamethasone and dapt was held until the month of february 2022 due to hematuria.Following day, the subject was also tested positive for covid-19 sars cov2 rna.In addition, valve study revealed a gradient of 30 mmhg across aortic valve concerning for low flow low gradient aortic stenosis.It was also noted that magnetic resonance imaging (mri)as unable to performed because of the subject metal penile pump.The subject chest x-ray has been performed and revealed an increase in consolidation throughout both lungs suggestive of progression of covid to ards and increase pulmonary vascular congestion.The subject was febrile and was noted with increasing fio2.The subject had nstemi and subsequent atrial fibrillation/atrial flutter with elevated cardiac enzyme with peak troponin t: 1120 ng/l; reference range: <=11 ng/l and ecg performed revealed: sinus rhythm, abnormal r-wave progression, inferior infarct repolarization abnormality suggesting ischemia, hence the subject was on heparin gtt.Five days later, subject creatinine was 2.35 mg/dl which was gradually increasing, fluid balance was 07 liters over the last three days, urine output had dropped over last 24 hours suggestive of aki however, renal ultrasound performed on the same day revealed no abnormality.Hence, continuous renal replacement therapy (crrt) and fluid replacement therapy was started.Subject was also noted with anemia due to long hospitalization with hemoglobin and rbc of 8.6g/dl (reference range: 13.5-17.0 g/dl) and 2.85 m/mm3 respectively and malnutrition with albumin 2.7 g/dl (reference range: 3.4-4.9 g/dl).Also, tracheostomy was performed after prolonged intubation as the subject was unable to wean from ventilator.The subject eeg performed revealed intermittent left temporal slowing suggestive of focal cerebral dysfunction and the degree of background slowing suggestive of mild encephalopathy of nonspecific etiology.The subject was kept on amiodarone drip due to atrial flutter and concern for demand ischemia.It was further reported that in may 2020, 99% stenosed was noted in non-target lesion distal rca and r-pda were treated by placement of 3.00mm x 20mm synergy stent.
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