Medtronic received information that this bioprosthetic valve, implanted less than one month, was explanted due to paravalular leak.I was reported that the surgeon had not observed any gaps in the sutures.In addition, they had used another manufacturer's knot pusher (cor knot).A couple of the clips did not seem to be completely tightened; however, the surgeon was hesitant to blame the knot pusher for the problem.It was reported that the patient is suffering from pulmonary edema with shortness of breath post-operatively, and the explanted valve will be returned for analysis.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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