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MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number EVOLUTR-26-C |
| Device Problems
Calcified (1077); Gradient Increase (1270); Incomplete Coaptation (2507); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Cardiomyopathy (1764); Dyspnea (1816); Endocarditis (1834); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Pleural Effusion (2010); Renal Failure (2041); Tachycardia (2095); Electrolyte Imbalance (2196); Cardiogenic Shock (2262); Low Oxygen Saturation (2477); Respiratory Failure (2484); Cognitive Changes (2551); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Respiratory Insufficiency (4462); Swelling/ Edema (4577)
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| Event Date 02/09/2023 |
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Event Type
Death
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Manufacturer Narrative
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Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.Product analysis: the product remains implanted; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that 5 years, 8 months, and 5 days following the implant of this transcatheter bioprosthetic valve, the patient presented to the emergency department with shortness of breath.Diuretics and oxygen were administered and the patient was hospitalized.Congestive heart failure (chf) was diagnosed.Surgical consult ordered due to transcatheter aortic valve (tav) failure.Three days after presenting the condition continued to deteriorate and was moved to an intensive care unit and was intubated prophylactically for transesophageal echocardiogram (tee).Patient coded in the cardiac catheterization laboratory while the procedure was being done and died after attempted resuscitation.The cause of death was reported to be cardiac arrest.No autopsy was performed.
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Manufacturer Narrative
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Updated data: b2, b5, b6, b7, h6 annex e, annex f, device codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received which indicated the patient¿s shortness of breath (sob) had occurred for ¿several¿ months prior to the emergency department presentation.An echocardiogram, from approximately 9 months prior to the emergency department presentation noted the following: septum appeared to be 1.3 centimeters at baseline, left ventricular hypertrophy (lvh), a mitral pressure half time (pht) of 101 and mitral valve area of 2.18, tricuspid velocity of 2.7 centimeters per second (cm/s), a pulmonary pressure of approximately 39 millimeters of mercury (mmhg).Approximately 7 months later, the patient had been discharged from the hospital due to a gastrointestinal bleed.An echocardiogram at that time noted a normal functioning transcatheter valve, no regurgitation with an ejection fraction of 75%, a mean gradient across the aortic valve of 8 mmhg with a peak gradient of 14 mmhg and a velocity of 1.84.A ¿dagger shaped¿ left ventricular outflow tract (lvot) doppler envelope may have been related to left ventricular hypertrophy, not significantly elevated at rest but increased to 31 mmhg with valsalva.There was progressive, not severe, mitral valve stenosis with a pht of 133, a mitral valve area of 1.65, a mitral peak gradient of 10 mmhg, a mitral mean gradient of 5 mmhg, mild to moderate mitral valve regurgitation, mitral annular calcification, and the mitral leaflets were mildly thickened.Moderate tricuspid valve regurgitation with a right ventricular systolic pressure (rvsp) of 49 mmhg were reported.With the reported emergency department visit for the worsened sob, the sob worsened with exertion and was better with rest.Fatigue, upper abdominal discomfort and fullness ¿like a band¿, which worsened after eating and improved lying down, had now also occurred for the last 2 days.As reported, the patient was compliant in taking diuretics.Oxygen saturation (spo2) measured 88%, hypoxia with note of mild respiratory distress was identified.Rales were present in the left-middle field, the right-lower and the left-lower fields.The spo2 measured 96% on three liters of oxygen delivered via nasal cannula.Acute congestive heart failure (chf) noted.A chest x-ray noted the heart size was enlarged, similar to prior.Central vascular congestion with patchy bilateral opacities suggested of pulmonary edema.Differential would include a generalized infectious process.A small right and a trace left pleural effusion were identified.Diuretics were administered.An echocardiogram with contrast and a transthoracic echocardiogram (tte) were performed.An ejection fraction of 43% and 45% were reported.Findings from these also noted the following: a mild to moderately reduced left ventricular systolic function, grade ii left ventricular diastolic dysfunction, new severe aortic valve regurgitation, new severe aortic stenosis, aortic regurgitation pht of 169.5 milliseconds (msec), a peak velocity across the aortic valve was 5.05 meters per second (m/s), a mean gradient of 63 mmhg, an aortic valve area (ava) of 0.7 cm2, v-max of 5, mild to moderate mitral valve regurgitation (mr), progressive, not severe, mitral valve stenosis (ms), mitral valve mean gradient of 5 mmhg and 7 mmhg, mild to moderate tricuspid valve regurgitation (tr) progressive, mild pulmonary hypertension (phtn), an estimated right ventricular systolic pressure of 48.0 mmhg.A transesophageal echocardiogram (tee) was also performed which indicated the transcatheter valve had a calcified immobile leaflet.A different leaflet appeared to mal-coapt and prolapse.It was difficult to exclude small vegetation due to sclerotic changes but not diagnostic.Possible subacute endocarditis (sbe) was reported.Cultures were to be ordered but results not reported.Severe intra-leaflet aortic insufficiency; 169 msec by pht.True severe prosthetic aortic stenosis noted.Mitral leaflet thickening with upper moderate mr.Tricuspid leaflet thickening with at least moderate tr and severe phtn, lvh, distal anterior hypokinesis, and left atrial appendage clear.The patien t had been sedated for the procedure and sent to the intensive care unit (icu) for recovery.The patient returned to baseline consciousness without complication.An electrocardiogram (ecg) noted normal sinus rhythm with no ectopy.S1 and s2 present with a regular rate and rhythm noted.Iii/vi systolic murmur loudest right upper sternal border (rusb).4/6 systolic murmur at base was also reported.There was no rub/gallop.Pulsatile jugular vein distention (jvd) at base of the neck.Bilevel positive airway pressure (bipap) was initiated but was not tolerated.A nasal high flow system was initiated with comfortable breathing for hypoxemic respiratory failure.Hypotension noted with possible cardiogenic shock.Blood pressure improved after intravenous (iv) diuresis.Acute on chronic diastolic congestive heart failure (chf) and hypertrophic obstructive cardiomyopathy noted.Acute kidney injury (aki) reported as multi-factoral with some level expected of renal compromise to control the heart failure.There was question if related to the contrast of the recent chest computed tomography (ct) scan.Occasional mild yellow sputum with no pulmonary pathology on ct noted.Anemia was stable with no bleeding.The elevated troponin was reported as likely a chronic injury pattern related to the heart failure.Further evaluation noted the following: s1, s2 present, regular rate and rhythm, grade 4/6 systolic murmur and 2/6 holodiastolic murmur, even respirations (unlabored, regular), peripheral 2+ lower extremity edema, and significant prosthetic dysfunction.Renal insufficiency was worse than baseline but stable overnight.Hypotension with the diastolic hypotension secondary to aortic insufficiency (al).Paroxysmal supra-ventricular tachycardia occurred and beta-blocker required, potassium replacement provide.The patient remained dyspneic/tachypneic.Lungs sounds were diminished with crackles, coarse rhonchi bibasilarly with left greater than the right, a non-productive cough, respirations even (regular, labored).A transcatheter aortic valve replacement (tavr) was recommended, if it was feasible for the patient.However, a cardiac catheterization reportedly would be needed to evaluate the coronary artery disease prior to any valve intervention.As reported, a cardiac catheterization was complicated by profound hypotension and suddenly and acutely became pulseless, unresponsive, with cardiopulmonary arrest.Pulseless electrical activity and ventricular tachycardia were reported.Bag-mask-valve (bmv) ventilation, intubation, cardiopulmonary resuscitation (cpr), and multiple defibrillations were required.Epinephrine was administered with no improvement in the hemodynamics.Further doses of epinephrine, atropine, and bicarbinate were administered.Pulses felt during cpr, but when checked patient had no spontaneous pulses detectable.Bedside ultrasound demonstrated no coordinated cardiac contractile activity.There was no evidence of pericardial effusion or tamponade.Blood sugar was noted to be in the 200s.Endotracheal tube was also checked for breath sounds, which were present in both lungs.Per nursing staff, the patient had no history of renal insufficiency and last creatinine was within normal.After approximately 15 more minutes of cpr, pulse checks, and considerations of any possible reversible etiology of the patient's cardiac arrest, it was determined further resuscitative efforts would not be successful.
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Event Description
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Additional information was received which indicated that cultures were performed but were negative.As reported, endocarditis was not confirmed.As reported, the transcatheter aortic valve had contributed to the mild-moderate mitral regurgitation and to the mild-moderate tricuspid regurgitation.The mitral stenosis was an unrelated patient condition.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Updated data: b5 and h6 annex e codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review report follows: transesophageal echocardiogram (tee) and transthoracic echocardiogram (tte) performed on (b)(6) 2023.Non-coronary cusp (ncc) leaflet appears thickened and frozen.Right coronary cusp (rcc) leaflet appears thickened, prolapses into the lvot, and a mobile echogenic structure appears to be on the rcc.Severe central aortic regurgitation seen.Aov v max is 4.92 m/s which is consistent with severe aortic stenosis.Moderate mitral regurgitation.Small patent foramen ovale (pfo)noted.A second tte was performed at 5:34 pm showing possible asystole with little cardiac movement.Medical safety reviewed the product event and assessed the reported: stenosis, regurgitation, calcification, cardiogenic shock, hypotension, heart failure, electrocardiogram (ecg) changes, cardiac arrest and death.Based on the information provided, it is likely that the primary harms of stenosis and regurgitation were related to the valve and contributed to the worsening heart failure and death.It is also likely that the patient history of left ventricular hypertrophy (lvh), congestive heart failure (chf) coronary artery disease and breast cancer treated with radiation were contributing factors to the patient death.All adverse events and severities noted in this event are documented in the risk management files and within the instructions for use (ifu).High gradients can be related to valve related factors (degeneration, thrombus, calcification, etc) or non-valve related factors (lvot obstruction, patient pressures, lv dysfunction, etc).Several factors can contribute to the onset and propagation of structural valve dysfunction (including calcification) such as patient medical history (age, disease stage, comorbidities, etc.), pharmacological factors, and/or intrinsic properties of the valve itself.Regurgitation can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.Mitral valve regurgitation is a potential adverse event associated with the implantation of the evolut valve and it can be attributed to factors such as valve position and implant depth where the depth can impinge on the mitral valve function or damage the mitral valve.Per the medical safety assessment, it is likely that the primary harms of stenosis and regurgitation were related to the valve.However, with the limited information available, a conclusive root cause of the mitral valve interaction / regurgitation could not be determined.Stenosis is a known potential adverse effect per the device ifu.Stenosis and coaptation issues of bioprosthetic valves can be a manifestation of structural valve dysfunction (e.G.Calcification), thrombosis, and/or non structural dysfunction (e.G.Pannus, obstruction, etc.).Several factors can contribute to the onset and propagation of either failure mechanism such as patient medical history (age, disease stage, comorbidities, etc.), pharmacological factors, and/or intrinsic properties of the valve itself.The reported ventricular tachycardia, ekg changes, and cardiac arrest are types of conduction disturbances.Conduction disturbances are known potential adverse effects per the device ifu.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations.A conclusive root cause could not be determined.Hypotension is a known potential adverse effect per the dev ice ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.Endocarditis cases that occur between 2 and 12 months after surgery are known to be a mixture of community-acquired episodes and hospital-acquired episodes caused by less virulent organisms.These cases may also be due to in troduction of the microorganism during the implant procedure.Heart failure (of which cardiogenic shock and chf are forms of) is listed in the device ifu under potential adverse events, and can be related to several factors (procedure, patient comorbidities, etc.).Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a tav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.Per the medical safety assessment, contributing factors of the heart failure and death include the primary harms of stenosis and regurgitation.It is also likely that the patient history of left ventricular hypertrophy (lvh), congestive heart failure (chf) coronary artery disease and breast cancer treated with radiation were contributing factors to the patient death.However, with the information available, a conclusive root cause for these events could not be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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