MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTPRO-29-US |
Device Problems
Gradient Increase (1270); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problems
Valvular Insufficiency/ Regurgitation (4449); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information that 4 years and 7 months following the implant of this transcatheter bioprosthetic valve, the valve failed due to an unknown reason.No treatment was provided.No adverse patient effects were reported.
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Manufacturer Narrative
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B3: date is approximate.Year is confirmed valid.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted. 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 that 4 years and 6 months following the valve implant, echocardiogram showed a mean gradient of 60 millimeters of mercury (mmhg) with a peak gradient of 89 mmhg.4 years and 7 months following the valve implant left ventricle end diastolic pressure (lvedp) peak-peak aortic valve gradient was 49 mmhg and mild paravalvular leak (pvl) was observed.There was concern for persistent or worsening prosthetic mismatch without significant weight loss.The patient was to proceed with aggressive weight loss.Per the physician, there is no evidence of valve failure and the computed tomography angiogram (cta) was negative for hypoattenuated leaflet thickening (halt).No additional adverse patient effects were reported.
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Manufacturer Narrative
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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.
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