Product analysis: the valve remains implanted 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 and seven days after the implant of this transcatheter bioprosthetic pulmonary valve, multiple fractures were noted which caused restriction and stenosis.Subsequently, the valve was stented and a second valve was implanted.No additional adverse patient effects were reported. .
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