Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.From the limited information received, the valve remained implanted.Without the return of the valve for analysis, a root cause of the stenosis and regurgitation cannot be determined.This report is being submitted as part of a historic clinical review of events contained within the medtronic melody bpv study.
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