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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Medtronic received information that five years, one month post implant of this bioprosthetic valve, this device was replaced, valve-in-valve with a transcatheter bioprosthetic valve due to aortic regurgitation.No other adverse patient effects were reported.
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