The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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On (b)(6) 2014, a 25mm masters series mechanical heart valve was implanted.On (b)(6) 2015, the patient reported dyspnea and presented with an inr of 4.3.Tte revealed a peak gradient of 64mm hg and a mean gradient of 30mm hg, an impeded mitral valve and an emergency mitral valve replacement (mvr) was performed.At surgery, a large thrombus was found inside the valve.Redo mvr was performed; however the patient expired (b)(6) 2015 day due to severe low cardiac output.Per report, the patient had been compliant with anti-coagulation therapy following the 2014 implant.Between (b)(6) 2015, the patient's inr ranged from 2.2-2.65.
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