Model Number 305U221 |
Device Problems
Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Device Stenosis (4066); Central Regurgitation (4068)
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Patient Problems
Aortic Valve Stenosis (1717); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 11/07/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that 10 years and 5 months post implant of this aortic bioprosthetic valve, a mild anterior paravalvular leak (pvl), mild to moderate aortic stenosis (as), mild to moderate aortic insufficiency (ai) and a mean gradient of 39mmhg were observed on a transthoracic echocardiogram (tte).It was also mentioned that peak aortic velocity was 4.3m/s.One month later, a computed tomography (ct) angiography showed the presence of diffuse calcification and consequent doming of the leaflet in the non coronary sinus due to mild to moderate diffuse calcification of the mid to distal leaflet.The aortic valve area was 1.1 cm2.Subsequently, 5 weeks later, a 23mm transcatheter valve was implanted valve-in-valve.The reason for intervention was reported as severe aortic stenosis (as) and mild aortic insufficiency (ai).No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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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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Search Alerts/Recalls
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