Model Number T505 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); No Information (3190)
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Event Date 11/22/2016 |
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.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 approximately four years, six months post implant of this bioprosthetic aortic valve, this valve was explanted and replaced.No failure mechanism and no other adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that this valve was explanted and replaced due to aortic valve stenosis and moderate prosthetic valve insufficiency.No other adverse patient effects were reported.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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