Medtronic received information that during the implant of this melody transcatheter pulmonary bioprosthetic valve, there was difficulty maintaining the lunderquist guidewire in position.Blood was noted in the endotracheal tube, and an angiogram and echocardiogram were performed.No blood was seen in the chest.The patient desaturated moderately; therefore the procedure was aborted.One day post-implant, no bleeding was reported and the patient was doing well.The patient will be evaluated for another valve replacement.There is no allegation against the function of any medtronic product.It was reported that the guidewire perforated the pulmonary artery.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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