(b)(4).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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A (b)(6) male patient was implanted with this 29 mm sjm mechanical heart valve on (b)(6) 2015.The patient complained of a dry cough with breathlessness for five days and on (b)(6) 2015, a 2-d echocardiogram showed peak/mean gradient across the mitral valve prosthesis at 44/32 mmhg.Also present was valve thrombosis with severe pah (rvsp~86mmhg).The patient was admitted and thrombolyzed with inj streptokinase (15 lac units) in infusion.On (b)(6) 2015 a second 2-d echocardiogram was performed and showed the peak/mean gradient across the mitral valve prosthesis at 22/11 mmhg, mva: 2.3q.Coms by pht, epasp: 31 mmhg.The patient was reported to be stable.
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