H10 additional narrative: the subject device is not available for evaluation as it remains implanted in the patient.Ct images were provided, the image provide did not clarify the event reported, the report states there is no calcium on the annulus or lvot.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|
Edwards received notification that a patient with a 21mm intuity valve implanted in aortic position underwent a valve-in-valve procedure after approximately five (5) years and ten (10) months implant duration due to valve degeneration leading to stenosis (mean gradient 39 mmhg by tte, an ava of 0.79 cm^2, indexed ava 0.4 cm^2/m^2 and aortic velocity 3.99 m/s,).Patient presented with fatigue before valve replacement a 20mm transcatheter heart valve was implanted within the edwards surgical valve in replacement.The patient passed away during surgery due the cardiac tamponade.
|
Added information to section h6 (investigation findings and investigation conclusions).The device was not returned to edwards for further investigation, as the valve remained implanted due to a valve-in-valve replacement), therefore customer report of degeneration could not be confirmed by product evaluation.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including renal chronic disease.
|