Model Number EVOLUTFX-29 |
Device Problems
Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Heart Block (4444); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 02/19/2024 |
Event Type
Injury
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, mild paravalvular leak (pvl) and complete atrio-ventricular (av) block was noted.No treatment was reported.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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Manufacturer Narrative
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Updated: b5 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 during implant of this transcatheter bioprosthetic valve, mild paravalvular leak (pvl) and complete atrio-ventricular (av) block was noted.No treatment was reported.No additional adverse patient effects were reported.Additional information was received that the final pvl classification was none.
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Search Alerts/Recalls
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