Product analysis: the valve was not returned therefore no product analysis can be performed.Conclusion: without 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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Medtronic received information that three years, four months and seven days following the implant of this transcatheter bioprosthetic pulmonary valve, the valve was surgically explanted and replaced with a medtronic surgical valve.The reason for explant and replacement was not reported.No additional adverse patient effects were reported.
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