Medtronic received information via literature regarding a (b)(6) male patient with a history of myxomatous mitral regurgitation who had undergone mitral valve repair with a 27 mm medtronic duran ancore annuloplasty ring (serial number not provided).At 18 months post-mitral valve repair, the patient presented with dyspnea (new york heart association functional classification iii) and the results of a physical examination were consistent with severe mitral stenosis.The patient¿s mean and end diastolic gradients were noted to be 14 mmhg and 12 mmhg, respectively.Echocardiography showed enlarged left atrium without clots.Subsequently, the duran ancore ring was explanted.During explantation, pannus overgrowth onto the ring was observed.It was reported that histopathological analysis of the ring revealed foreign body giant cell reactions with a neo-myocardial patch surrounding the ring.No additional adverse patient effects or product performance issues were reported.
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