Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: without the 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 during the implant of this transcatheter bioprosthetic valve, after deployment, aortic dissection was noted.Open surgery was performed to repair the aortic root, at which point the transcatheter valve was replaced with a surgical valve.Per the physician, the cause of the dissection was not known but was possibly related to the valve.It was noted that the patient had a bicuspid native aortic valve and enlarged ascending aorta.No additional adverse patient effects were reported.
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