Medtronic received information that 8 years 3 months following implant of this bioprosthetic aortic valve and root, the patient presented with class iv angina.Catheterization demonstrated a 99% stenosis in the origin of the graft of the left anterior descending (lad) artery, with 75% diffuse stenosis in the graft to the right coronary artery.Separate stents were placed via catheters in the lad and right coronary arteries with 0% residual stenosis in both instances.Subsequently, the patient presented with a 6.1 cm aneurysm.No intervention and no other adverse patient effects were reported at that time.Additional information was received that 9 years and 7 months post implant of this bioprosthetic valve, the valve was explanted and replaced with a non-medtronic conduit due to an aortic aneurysm.Echocardiogram reported stenosis and mild to moderate regurgitation were present.No adverse patient effects were reported.
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Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed that two pieces of tissue were received; a freestyle and a vein graft.The free edge of the sewing cloth on the valve showed explant damage, therefore it could not be confirmed if the cloth was everted.Green multifilament and blue monofilament sutures were found sutured along the damaged sewing cloth and on multiple areas of the aortic wall of both pieces.The pieces appeared to have been cauterized during explant.All the leaflets¿ commissures were intact and were still attached to the aortic wall.Traces of pannus were found at the left right commissure.All leaflets (inflow) were stiff and thickened by thrombus.However, the lunulas of all three leaflets were flexible and appeared wavy.Visible pannus lined the margin of attachment of the right coronary cusp encroaching to the tunica approximately 1 mm to 3 mm.The tissue wall of the valve was thinned out.Evident pseudoaneurysm was observed at the left aortic wall above the left coronary sinus.It appeared to be adjacent to the left coronary cusp leaflet attachment.It appeared that the right coronary and non-coronary had been modified.The right coronary sinus appeared to have been excised during modification.A small perforation (possibly pseudoaneurysm) was observed on the non-coronary wall.Blue monofilament suture was found attached to the small perforation.Radiography did not reveal any evidence of calcification in the valve tissue.A review of the device history record (dhr) could not be performed as the serial number was not provided.The transthoracic echocardiograms reviewed prior to explant revealed evidence of saphenous vein graft disease and aortic root aneurysm.The underlying aortic valve lesion precipitating aortic valve replacement is not known.However, patients with aortic stenosis and coronary artery disease often have risk factors for aortic aneurysm, including hypertension and dyslipidemia.Patients with a bicuspid aortic valve are at risk of bicuspid aortopathy, which can progress after aortic valve replacement.Mild and then mild-to-moderate aortic regurgitation were noted on serial echocardiography.With only mild focal sclerosis of the aortic bioprosthesis, a likely etiology is aortic root dilation leading to leaflet malcoaptation of the stentless valve leaflets.Based on the echo over-read and the limited information available, a root cause of the stenosis cannot be determined.If information is provided in the future, a supplemental report will be issued.
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