Citation: mceachern w et al.Intravascular hemolysis as the first indication of melody valve failure.Journal of the american college of cardiology.2020 march; 75(11):2800 supplement 1.Doi: 10.1016/s0735-1097(20)33427-6.Published online march 16, 2020.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via a literature case report regarding a 15-year-old male patient with repaired tetralogy of fallot and a 20 mm pulmonary homograft who underwent transcatheter valve-in-valve implantation with a medtronic melody transcatheter pulmonary valve (serial number not provided).Prior to melody valve implant, two non-medtronic stents were implanted and post-dilated.The melody valve was noted to have been deployed in an optimal position.Immediately after valve implant, a peak-to-peak gradient of 15 mmhg was observed.At an unspecified time later, the patient presented with tea-colored urine.Initial laboratory results showed blood in the urine (4+), decreased hemoglobin (12.7 g/dl), decreased haptoglobin level, and increased lactate dehydrogenase.An echocardiogram exhibited a peak gradient of 30 mmhg with a mean of 20 mmhg.The patient was treated with intravenous hydration and was discharged three days later with resolution of hemoglobinuria.Three weeks later, the patient¿s laboratory results indicated continued mild hemolytic anemia and an echocardiogram revealed a peak gradient of 51 mmhg.Subsequently, a repeat catheterization was performed.A ¿significant¿ stenosis of the melody valve was observed with an elevated right ventricular pressure of 95 mmhg and a transvalvular gradient of 63 mmhg.Fluoroscopy showed mid-stent narrowing but did not identify any stent fractures on the valve frame.The valve was re-dilated with a 22 mm x 2 cm non-medtronic balloon with an increase in caliber of 2 mm.After the balloon dilation, it was reported that the valve frame appeared homogenous with no obvious area of narrowing and a transvalvular gradient of 4 mmhg was noted.Two months later, an echocardiogram showed a peak gradient of 27 mmhg with a mean of 16 mmhg.No additional adverse patient effects or product performance issues were reported.
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