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 approximately eight years, six months following the implant of this transcatheter pulmonary bioprosthetic valve, the patient presented with heart failure and a moderately diseased valve.The valve was inside a heavily calcified right ventricle to pulmonary artery non-medtronic conduit.It was also reported that some metal, presumably from the valve, had perforated the aorta near the lesser curvature portion of the aortic arch.Subsequently, the non-medtronic conduit and valve were explanted and replaced with a medtronic surgical valve.An aortic root and arch replacement also took place.No additional adverse patient effects were reported.
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