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Model Number 505DA24 |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problems
Regurgitation, Valvular (2335); No Information (3190)
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Event Date 06/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 one day post implant of this mechanical valve, paravalvular (pvl) regurgitation was noted.Re-operation was performed, and the surgeon rotated the valve and included additional suturing at the location where the pvl was observed.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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