Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Since the valve has been implanted for over a year, it¿s very unlikely that the stenosis is due to any potential manufacturing issue.The valve remains implanted.Without the return of the valve for analysis, a root cause of the stenosis cannot be determined.This report is being submitted as part of a historic clinical review of events contained within the medtronic melody tpv: post-approval study of original ide cohort (pas1 study.
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