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.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that 3 years and 11 months post implant of this aortic bioprosthetic valve, a transcatheter bioprosthetic valve was implanted valve-in-valve.The reason for the intervention was reported as aortic stenosis and a gradient measurement of 40 mmhg.No additional adverse patient effects were reported.Additional information: it was reported that within a few days following implant, the gradient was 20 mmhg.
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