MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTR-34-C

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Cardiomyopathy (1764); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Cardiogenic Shock (2262); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/03/2024

Event Type  Death  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that approximately four years, five and a half months following the implant of this transcatheter bioprosthetic valve, an echocardiogram was performed which revealed a decline in the patient's ejection fraction and moderate aortic stenosis; however, no baseline, post-valve implant, nor current values were reported.Five days later, the patient was seen by a cardiologist who identified non-ischemic cardiomyopathy.Approximately one and a half months later, the patient was seen by a cardiac surgeon for evaluation.A recommendation was made for computed tomography angiography of the transcatheter aortic valve followed by discussion at the structural heart conference to determine treatment.However, one week after the appointment with the cardiac surgeon, the patient began to experience shortness of breath.The patient was transferred via emergency medical services to the emergency department.A chest x-ray was performed and showed pulmonary edema and pleural effusions.The patient was admitted and medications were administered via intravenous therapy.Therapeutic efforts were unsuccessful and the patient died nine days after admission.The cause of death was not reported, but the classification was reported as non-sudden cardiac death.It is unknown if an autopsy was performed.

Event Description

Additional information received indicated that there was a history of ejection fraction dysfunction and chemotherapy for chronic lymphocytic leukemia (cll).Cardiomyopathy was previously diagnosed approximately 3 years previously with an ejection fraction of 40% at that time.As reported, the patient had low-flow, low gradient bioprosthetic aortic valve stenosis and unspecified insufficiency.At the time of this event, the ejection fraction measured 26%.An echocardiogram revealed a mean gradient of 31 millimeters of mercury (mm hg) and a peak velocity of 3.42 meters per second (m/s).At the time the patient was seen by the cardiologist for the moderate stenosis and valve evaluation, acute on chronic heart failure was noted.A combination of systolic and diastolic congestive heart failure was reported.An echocardiogram was performed 7 days following hospital admission due to the heart failure, cardiomyopathy, pulmonary edema, and cardiogenic shock.These were reported as probably causation to the valve stenosis.Hemodynamic support was required.The echocardiogram identified an ejection fraction of 11%.The reported deteriorating left ventricular function was thought to be secondary to the aortic stenosis.Respiratory failure developed and required endotracheal intubation.The patient remained ill in the intensive care unit (icu) and was unable to be weaned from the ventilatory.The patient was considered to no longer be a candidate for aortic valve replacement.Palliative aortic valvuloplasty was being considered due to the critical condition.Additional treatment included aggressive diuresis.The patient¿s condition had further deteriorated and 3 vasopressors were required for cardioversion of a wide complex ventricular tachycardia.At this time, the patient was also no longer a candidate for valvuloplasty due to the critical condition.The patient requested a do not resuscitate (dnr) status.The following day the patient died.As reported, there was a probable causal relation to the valve stenosis.An autopsy was not performed.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received which indicated that approximately 2 and a half years following the valve implant the ejection fraction measured 40%.Approximately 3 years and 3 months following the valve implant non-ischemic cardiomyopathy was identified.Cardiology had noted the cardiomyopathy at that time and the cardiomyopathy up through approximately 4 years and 6 months following the valve implant, may have been related to the aortic stenosis verses chemotherapy for the chronic lymphocytic leukemia.The echocardiogram, performed approximately 4 years and 8 months following the valve implant, identified the aortic insufficiency specific as mild paravalvular leak (pvl).

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that approximately four years, five and a half months following the implant of this transcatheter bioprosthetic valve, an echocardiogram was performed which revealed a decline in the patient's ejection fraction and moderate aortic stenosis; however, no baseline, post-valve implant, nor current values were reported.Five days later, the patient was seen by a cardiologist who identified non-ischemic cardiomyopathy.Approximately one and a half months later, the patient was seen by a cardiac surgeon for evaluation.A recommendation was made for computed tomography angiography of the transcatheter aortic valve followed by discussion at the structural heart conference to determine treatment.However, one week after the appointment with the cardiac surgeon, the patient began to experience shortness of breath.The patient was transferred via emergency medical services to the emergency department.A chest x-ray was performed and showed pulmonary edema and pleural effusions.The patient was admitted and medications were administered via intravenous therapy.Therapeutic efforts were unsuccessful and the patient died nine days after admission.The cause of death was not reported, but the classification was reported as non-sudden cardiac death.It is unknown if an autopsy was performed.Additional information received indicated that there was a history of ejection fraction dysfunction and chemotherapy for chronic lymphocytic leukemia (cll).Cardiomyopathy was previously diagnosed approximately 3 years previously with an ejection fraction of 40% at that time.As reported, the patient had low-flow, low gradient bioprosthetic aortic valve stenosis and unspecified insufficiency.At the time of this event, the ejection fraction measured 26%.An echocardiogram revealed a mean gradient of 31 millimeters of mercury (mm hg) and a peak velocity of 3.42 meters per second (m/s).At the time the patient was seen by the cardiologist for the moderate stenosis and valve evaluation, acute on chronic heart failure was noted.A combination of systolic and diastolic congestive heart failure was reported.An echocardiogram was performed 7 days following hospital admission due to the heart failure, cardiomyopathy, pulmonary edema, and cardiogenic shock.These were reported as probably causation to the valve stenosis.Hemodynamic support was required.The echocardiogram identified an ejection fraction of 11%.The reported deteriorating left ventricular function was thought to be secondary to the aortic stenosis.Respiratory failure developed and required endotracheal intubation.The patient remained ill in the intensive care unit (icu) and was unable to be weaned from the ventilatory.The patient was considered to no longer be a candidate for aortic valve replacement.Palliative aortic valvuloplasty was being considered due to the critical condition.Additional treatment included aggressive diuresis.The patient¿s condition had further deteriorated and 3 vasopressors were required for cardioversion of a wide complex ventricular tachycardia.At this time, the patient was also no longer a candidate for valvuloplasty due to the critical condition.The patient requested a do not resuscitate (dnr) status.The following day the patient died.As reported, there was a probable causal relation to the valve stenosis.An autopsy was not performed.Additional information was received which indicated that approximately 2 and a half years following the valve implant the ejection fraction measured 40%.Approximately 3 years and 3 months following the valve implant non-ischemic cardiomyopathy was identified.Cardiology had noted the cardiomyopathy at that time and the cardiomyopathy up through approximately 4 years and 6 months following the valve implant, may have been related to the aortic stenosis verses chemotherapy for the chronic lymphocytic leukemia.The echocardiogram, performed approximately 4 years and 8 months following the valve implant, identified the aortic insufficiency specific as mild paravalvular leak (pvl).

Manufacturer Narrative

Updated data: product analysis: the valve remained implanted, so it was not returned to medtronic for analysis.Procedural images were submitted to medtronic for review.The transthoracic echocardiogram (tte) performed three years, ten and a half months following valve implant showed the valve implant depth appeared deep.The posterior mitral valve leaflet was calcified with limited mobility.There was mild mitral and tricuspid regurgitation and trivial central aortic insufficiency.Ivc is dilated with a diameter measuring 23.0 mm.Aortic valve mean pressure gradient is 21 mm hg with an ejection fraction at approximately 35-40%.A tte was performed four and a half years after valve implanted and images revealed a large pleural effusion.Mild-moderate tricuspid and mitral valve regurgitation.The aortic valve mean pressure gradient was 29 mm hg.Central ai pht is 424 ms suggesting moderate regurgitation.Ivc was dilated with a diameter measuring 24.1 mm.Ejection fraction was approximately 25-30%.The tte performed four years, seven and a half months following valve implant showed the large pleural effusion remained.There was mild-moderate tricuspid regurgitation and mild mitral regurgitation.Aortic insufficiency interrogation was not provided.Ivc is within normal range with a diameter measuring 18.5 mm.The aortic valve mean pressure gradient was 29 mm hg with an ejection fraction at approximately 10-15%.Conclusion: unfortunately, the failure mechanism of the device cannot be established, and the conclusive cause cannot be determined.With the li mited information available, a relationship between the device and the adverse events could not be established.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18971564
• MDR Text Key: 338514051
• Report Number: 2025587-2024-01885
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: EVOLUTR-34-C
• Device Catalogue Number: EVOLUTR-34-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/22/2024; 04/04/2024; 05/09/2024
• Supplement Dates FDA Received: 04/02/2024; 04/08/2024; 05/14/2024
• Date Device Manufactured: 06/28/2019
• 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): Required Intervention; Death; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White