MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 40029 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Atrial Fibrillation (1729)
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Event Date 08/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).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 2 days post implant of this 29mm aortic bioprosthetic valve, atrial fibrillation was reported.M edications were prescribed.Seven days post implant, cardioversion was performed which returned the patient to normal sinus rhythm.No adverse patient effects were reported.
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Event Description
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Medtronic received additional information that 1 day post implant of this 29mm aortic bioprosthetic valve, atrial fibrillation and atrial flutter were reported and antiarrhythmic medication was given.Subsequently 6 days later, cardioversion was performed due to persistent arrythmia.It was stated that the patient "has been in and out of atrial fibrillation for the past few years and was diagnosed with paroxysmal atrial fibrillation".It was reported that 1 year 10 months post implant of the 29mm aortic bioprosthetic valve, cardioversion was performed and antiarrhythmic medications were given.No additional adverse patient effects were reported.
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Manufacturer Narrative
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B3: updated b5: updated fdc and imf codes updated 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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