Medtronic received information that 16 years 10 months post implant of this mitral annuloplasty ring, the patient presented with persistent hypotension and acute chronic congestive heart failure with worsening symptoms including shortness of breath and fatigue.A transesophageal echocardiogram (tee) showed severe mitral stenosis and severe mitral insufficiency.The physician stated that the annuloplasty ring appeared to be overly small, and the regurgitation appeared to be due to tethering of the posterior and anterior leaflets.The physician explanted the device, performed a debridement of the mitral valve from an investing scar, and implanted a 27mm annuloplasty band.No evidence of mitral regurgitation or mitral stenosis was observed post implant.No further adverse patient effects were reported.
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