MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10603

Device Problem Obstruction of Flow (2423)

Patient Problems Anemia (1706); Chest Pain (1776); Fever (1858); Ischemia (1942); Myocardial Infarction (1969); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 02/02/2021

Event Type  Death  

Manufacturer Narrative

Patient identifier:(b)(6).Initial reporter facility name: (b)(6).

Event Description

Same case as pr id# (b)(6).Evolve_lv_xlv.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% with timi flow 3.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 2.25 mm x 32 mm synergy stent and 3.00 mm x 28 mm synergy stent in distal rca.Electrocardiogram (ecg) revealed sinus rhythm, borderline prolonged pr interval, right bundle branch block and in (b)(6) 2021, revealed sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject experienced cardiac arrest and 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 revealed acute 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.During catherization, subject underwent bilateral selective coronary angiography which revealed left main coronary artery (lmca) free of flow limiting disease and bifurcates into left anterior descending (lad)and left circumflex (lcx) coronary artery, lcx with 80 - 85% severe high-grade stenosis in ostial native left circumflex stenosis and 70 - 80% focal stenosis in mid obtuse marginal 2 (om2), lad chronic total occlusion in proximal segment right after it takes off from lmca, dominant vessel giving rise to right- pda and right posterolateral artery (rpl).Stent in ostial segment, proximal rca and another stent in distal rca extending into proximal pda.The proximal pda, distal rca, proximal rpl had a large burden of clot.The saphenous vein graft (svg)-pda was chronically occluded, and svg-da1 was patent with 90% high grade stenosis on the diagonal with timi flow 2 downstream.Left internal mammary artery (lima) to the left anterior descending artery (lad) atretic vessel with no downstream flow.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.On the same day.The subject underwent several diagnostic tests which revealed, sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct and subsequent ecg revealed atrial fibrillation, non-specific intraventricular conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin.The thrombus in distal rca and pda-pla (posterolateral artery) bifurcation was treated with penumbra thrombectomy.Following which, intravascular ultrasound (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 and timi flow 3.Following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics.Five days later, the subject ecg/ekg was again revealed sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.It was performed revealed multiple ill-defined hypo densities 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.The chest x-ray performed which shows, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Eleven 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.The borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury and cardiac enzymes were found to be elevated with peak troponin.Thirteen days later, repeat ecg revealed atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.The following day, ecg revealed atrial flutter, inferior infarct.Fifteen days later, cardiac enzyme was found to be elevated with peak troponin t.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.The following day, amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Two weeks and three days later, chest x-ray revealed diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.On the same day, chest x-ray revealed diffuse airspace opacities in both lungs.The following day, chest x-ray revealed diffuse airspace opacities in both lungs.The subject was started on crrt for aki with creatinine: 2.35 mg/dl which was gradually increasing from past 5 days.Two weeks and five days later, chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, on (b)(6) -2021 chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and on (b)(6) 2021, chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Three weeks later, ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Three weeks and one day later, chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left.The following day, 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.Three weeks and three days later, chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.The following day, subject underwent several diagnostic tests.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 with peak troponin t.Three weeks and five days later, 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.On the same day, ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation and cardiac enzyme was elevated with peak troponin t.In (b)(6) 2021, considering the condition of anoxic brain injury subject was switched to do-not-resuscitate (dnr) and do-not-intubate (dni) and transitioned to comfort care and compassionate extubating was done.The subject expired in hospital at 16:08 due to stemi.Per death certificate, immediate cause of death was due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.Other significant conditions contributing to death but not resulting in the underlying cause was covid-19 and autopsy was not performed.

Manufacturer Narrative

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).

Event Description

Same case as pr id# (b)(4).Evolve_lv_xlv 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% with timi flow 3.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 2.25 mm x 32 mm synergy stent and 3.00 mm x 28 mm synergy stent in distal rca.Electrocardiogram (ecg) revealed sinus rhythm, borderline prolonged pr interval, right bundle branch block and in (b)(6) 2021, revealed sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject experienced cardiac arrest and 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 revealed acute 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.During catherization, subject underwent bilateral selective coronary angiography which revealed left main coronary artery (lmca) free of flow limiting disease and bifurcates into left anterior descending (lad)and left circumflex (lcx) coronary artery, lcx with 80 - 85% severe high-grade stenosis in ostial native left circumflex stenosis and 70 - 80% focal stenosis in mid obtuse marginal 2 (om2), lad chronic total occlusion in proximal segment right after it takes off from lmca, dominant vessel giving rise to right- pda and right posterolateral artery (rpl).Stent in ostial segment, proximal rca and another stent in distal rca extending into proximal pda.The proximal pda, distal rca, proximal rpl had a large burden of clot.The saphenous vein graft (svg)-pda was chronically occluded, and svg-da1 was patent with 90% high grade stenosis on the diagonal with timi flow 2 downstream.Left internal mammary artery (lima) to the left anterior descending artery (lad) atretic vessel with no downstream flow.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.On the same day.The subject underwent several diagnostic tests which revealed, sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct and subsequent ecg revealed atrial fibrillation, non-specific intraventricular conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin.The thrombus in distal rca and pda-pla (posterolateral artery) bifurcation was treated with penumbra thrombectomy.Following which, intravascular ultrasound (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 and timi flow 3.Following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics.Five days later, the subject ecg/ekg was again revealed sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.It was performed revealed multiple ill-defined hypo densities 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.The chest x-ray performed which shows, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Eleven 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.The borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury and cardiac enzymes were found to be elevated with peak troponin.Thirteen days later, repeat ecg revealed atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.The following day, ecg revealed atrial flutter, inferior infarct.Fifteen days later, cardiac enzyme was found to be elevated with peak troponin t.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.The following day, amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Two weeks and three days later, chest x-ray revealed diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.On the same day, chest x-ray revealed diffuse airspace opacities in both lungs.The following day, chest x-ray revealed diffuse airspace opacities in both lungs.The subject was started on crrt for aki with creatinine: 2.35 mg/dl which was gradually increasing from past 5 days.Two weeks and five days later, chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, on (b)(6) 2021 chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and on (b)(6) 2021, chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Three weeks later, ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Three weeks and one day later, chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left.The following day, 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.Three weeks and three days later, chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.The following day, subject underwent several diagnostic tests.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 with peak troponin t.Three weeks and five days later, 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.On the same day, ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation and cardiac enzyme was elevated with peak troponin t.In (b)(6) 2021, considering the condition of anoxic brain injury subject was switched to do-not-resuscitate (dnr) and do-not-intubate (dni) and transitioned to comfort care and compassionate extubating was done.The subject expired in hospital at 16:08 due to stemi.Per death certificate, immediate cause of death was due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.Other significant conditions contributing to death but not resulting in the underlying cause was covid-19 and autopsy was not performed.It was further reported that in (b)(6) 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 (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.

Manufacturer Narrative

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).

Event Description

Same case as pr id# (b)(4).Evolve_lv_xlv.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 (b)(4) 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% with timi flow 3.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 2.25 mm x 32 mm synergy stent and 3.00 mm x 28 mm synergy stent in distal rca.Electrocardiogram (ecg) revealed sinus rhythm, borderline prolonged pr interval, right bundle branch block and in (b)(6) 2021, revealed sinus rhythm, left atrial enlargement, left ventricular hypertrophy, non-specific t abnormality.On the same day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject experienced cardiac arrest and 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 revealed acute 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.During catherization, subject underwent bilateral selective coronary angiography which revealed left main coronary artery (lmca) free of flow limiting disease and bifurcates into left anterior descending (lad)and left circumflex (lcx) coronary artery, lcx with (b)(4) severe high-grade stenosis in ostial native left circumflex stenosis and (b)(4) focal stenosis in mid obtuse marginal 2 (om2), lad chronic total occlusion in proximal segment right after it takes off from lmca, dominant vessel giving rise to right- pda and right posterolateral artery (rpl).Stent in ostial segment, proximal rca and another stent in distal rca extending into proximal pda.The proximal pda, distal rca, proximal rpl had a large burden of clot.The saphenous vein graft (svg)-pda was chronically occluded, and svg-da1 was patent with (b)(4) high grade stenosis on the diagonal with timi flow 2 downstream.Left internal mammary artery (lima) to the left anterior descending artery (lad) atretic vessel with no downstream flow.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.On the same day.The subject underwent several diagnostic tests which revealed, sinus rhythm, borderline ivcd with lad, abnormal r wave progression, inferior infarct and subsequent ecg revealed atrial fibrillation, non-specific intraventricular conduction delay, inferior infarct, probable rv involvement, baseline wander in leads.Cardiac enzymes were found to be elevated, consistent with protocol and universal definition of spontaneous mi with peak troponin.The thrombus in distal rca and pda-pla (posterolateral artery) bifurcation was treated with penumbra thrombectomy.Following which, intravascular ultrasound (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 and timi flow 3.Following day, subject went into shock secondary to cardiogenic shock and subject was started on empiric antibiotics.Five days later, the subject ecg/ekg was again revealed sinus tachycardia, prolonged pr interval, probable left atrial enlargement, inferior infarct.It was performed revealed multiple ill-defined hypo densities 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.The chest x-ray performed which shows, cardiomegaly, four quadrant airspace disease within lungs and sputum culture revealed, presence of gram-positive cocci.Eleven 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.The borderline left axis deviation, repolarization abnormalities, probable ischemia in anterolateral leads, st elevation suggesting inferior injury and cardiac enzymes were found to be elevated with peak troponin.Thirteen days later, repeat ecg revealed atrial flutter/fibrillation, probable inferior infarct, repolarization abnormality suggests of ischemia.Ct brain performed revealed no acute intracranial abnormalities.The following day, ecg revealed atrial flutter, inferior infarct.Fifteen days later, cardiac enzyme was found to be elevated with peak troponin t.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.The following day, amiodarone gtt was started for atrial fibrillation with rvr, and discontinued within 12hrs with regular rates.Two weeks and three days later, chest x-ray revealed diffuse airspace opacities in both lungs with no pneumothorax and pleural effusion.On the same day, chest x-ray revealed diffuse airspace opacities in both lungs.The following day, chest x-ray revealed diffuse airspace opacities in both lungs.The subject was started on crrt for aki with creatinine: 2.35 mg/dl which was gradually increasing from past 5 days.Two weeks and five days later, chest x-ray performed revealed unchanged bilateral airspace change with no pneumothorax and sizeable effusion, on (b)(6) 2021 chest x-ray performed revealed unchanged extensive diffuse airspace changes in both lungs and on (b)(6) 2021, chest x-ray performed revealed, diffuse airspace disease throughout the lungs, unchanged bilateral infiltrates.Three weeks later, ecg performed revealed atrial flutter, left axis deviation, repolarization abnormality, severe global ischemia.Three weeks and one day later, chest x-ray revealed, extensive bilateral infiltrates with some improvements on the left.The following day, 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.Three weeks and three days later, chest x-ray performed revealed, unchanged extensive diffuse airspace changes in both lungs, unchanged cardio media sternal structures.The following day, subject underwent several diagnostic tests.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 with peak troponin t.Three weeks and five days later, 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.On the same day, ecg performed revealed, atrial fibrillation, boarder line left axis deviation, repolarization abnormality suggestive of ischemia, minimal st elevation and cardiac enzyme was elevated with peak troponin t.In (b)(6) 2021, considering the condition of anoxic brain injury subject was switched to do-not-resuscitate (dnr) and do-not-intubate (dni) and transitioned to comfort care and compassionate extubating was done.The subject expired in hospital at 16:08 due to stemi.Per death certificate, immediate cause of death was due to anoxic brain injury which was a consequence of cardiogenic shock and stemi.Other significant conditions contributing to death but not resulting in the underlying cause was covid-19 and autopsy was not performed.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 (b)(4).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.It was further reported that in (b)(6) 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.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13791994
• MDR Text Key: 287316653
• Report Number: 2134265-2022-02989
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024977245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White