Medtronic received information via literature regarding two case reports in which intracardiac echocardiography identified unique complications associated with the melody valve.Patient 2: a (b)(6)-year-old male patient with a history of truncus arteriosus and two reoperations for replacement of the right ventricle to pulmonary artery conduit.At age 29, he had a 22 mm medtronic melody transcatheter pulmonary valve (serial number not provided) implanted in the existing right ventricle to pulmonary artery homograft due to regurgitation and stenosis.Three years later, the patient presented with acute right heart failure with pedal edema, hepatomegaly, and limited exercise capacity.A transthoracic echocardiogram showed severe stenosis of the melody valve with an elevated peak gradient (80 mmhg).A cardiac catheterization with intracardiac echocardiogram was performed and revealed loss of contact between the valve and the valve stent which produced a ¿hammocking¿ movement causing severe regurgitation and stenosis.Subsequently, a second 22 mm melody valve (serial number not provided) was implanted valve-in-valve.Two years later, it was reported that the second melody valve showed good function with mild residual stenosis.No additional adverse patient effects or product performance issues were reported.
|