MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 40023 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Hypoxia (1918); Ventricular Fibrillation (2130); Multiple Organ Failure (3261); Cerebral Edema (4403)
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Event Date 11/19/2020 |
Event Type
Death
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Event Description
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Medtronic received information that 5 years and 6 months post implant of this 23 mm aortic bioprosthetic valve, the patient died.The cause of death was reported as ventricular fibrillation and pronounced hypoxia.It was stated that the patient was found unconscious at their home and resuscitation was performed for ventricular fibrillation and medications were administered, however, the patient died 2 days later as a result of pronounced hypoxia.It was reported that a computed tomography (ct) scan of the skull showed pronounced cerebral edema with severe hypoxic brain damage.It was noted that the patient experienced multiple organ failure.The site assessed the event as not related to the valve or implant procedure.It is unknown whether an autopsy was performed.
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Manufacturer Narrative
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This regulatory report is being submitted as part of a retrospective review and remediation 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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Manufacturer Narrative
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A supplemental report is being submitted for correction to h10 of the previous report to reference the capa #.This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) related to capa pr 564122.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.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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