MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTPRO-23 |
Device Problem
Degraded (1153)
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Patient Problems
Aortic Valve Stenosis (1717); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Pulmonary Edema (2020); Pericardial Effusion (3271); Myocardial Hypertrophy (4447)
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Event Date 10/01/2022 |
Event Type
Injury
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Event Description
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Medtronic received information via literature regarding a 67-year-old male patient who underwent implant of a medtronic evolut pro b ioprosthetic valve (unique device identifier numbers not provided) to treat aortic stenosis. the patient also had end-stage renal disease, hyperlipidemia, hypertension, latent tuberculosis and peptic ulcer disease. subsequently, the patient presented to the hospital with shortness of breath requiring oxygen support. a chest radiograph showed bilateral pulmonary edema and pleural effusions.A 12-lead electrocardiogram revealed first degree atrio-ventricular block and a new left bundle branch block. a 2d echocardiogram confirmed left ventricular hypertrophy, dilated left atrium, ejection fraction of 40-45% and aortic stenosis.Transesophageal echocardiogram demonstrated aortic valve dysfunction with a mean valve gradient of 18.9 mmhg. finally, the patient was diagnosed with severe bioprosthetic aortic valve stenosis and transferred to another facility for reintervention. no additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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Citation: kedarisetti et al.Bioprosthetic aortic valve failure in end-stage renal disease and reintervention.Cardiovascular disease.Vol 162, issue 4, supplement a142-a143, october 01, 2022.Https://doi.Org/10.1016/j.Chest.2022.08.102.Presented at nashville chest conference october 19, 2022.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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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