Model Number FR99525 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/23/2024 |
Event Type
Death
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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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Event Description
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Medtronic received information that 17 years and 2 months post implant of this aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement.The reason for evaluation was not reported.It was stated that the patient was hospitalized.No intervention or adverse patient effects were reported.
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Event Description
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Medtronic received additional information 17 years and 3 months post implant of this aortic bioprosthetic valve, the patient died.The cause of death was not received.Therefore, relatedness of the death to the valve could not be excluded.It is unknown whether an autopsy was performed.
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Manufacturer Narrative
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B5: updated b2: updated b2: date of death (year valid) fdm (annex b) and imf (annex f) 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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Search Alerts/Recalls
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