Manufacturer was notified that patient who had mitroflow dla 25 mm valve implanted on (b)(6) 2016 underwent aortic valve replacement on (b)(6) 2018, due to stenosis.The valve leaflets were reportedly thickened and rigid.The device was replaced with a st.Jude regent 23 mm mechanical valve, and the patient outcome was good.
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Radiographic review of the returned device confirmed the presence of intrinsic calcification in all of the leaflets.Hystopathologic analysis confirmed the presence of pannus over the free edges of both leaflets surrounding one of the valve posts, which contributed to the observed stenosis of the valve.All leaflets were stiffened due to intrinsic and vegetating calcifications.Small thrombus depositions were visible on the inflow surfaces.Gram staining showed some focal gram positive bacteria.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla25, s/n # (b)(4), as they pertain to the reported event, were pulled and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla25 mitroflow aortic pericardial heart valve at the time of manufacture and release.As reported among the contraindications in the mitroflow dla instructions for use, patients "who are 55 years of age or less may have an increased tendency toward calcification of valvular bioprostheses." as such, the patient's age ((b)(6)) was a risk factor for early structural valve deterioration, and a contraindication for use of the mitroflow dla, and thus may have contributed to the reported failure of this device.
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