On (b)(6) 2011, the patient underwent an aortic valve replacement where this 23 mm sjm trifecta valve was implanted due to aortic stenosis.The patient was admitted to the hospital on (b)(6) 2012 due to streptococcus and staphylococcus endocarditis.There was abscess formation below the prosthesis in the intravalvular connective tissue.Antibiotics were administered.On (b)(6) 2012, the aortic valve was explanted and it was noted to be completely encapsulated with vegetation.A 21 mm sjm epic supra valve was implanted in the aortic position.Concomitant mitral valve replacement was also performed with a 29 mm sjm epic valve implanted in the mitral position.Postoperatively, the patient was transferred to the icu.On (b)(6) 2012, the patient died of multi-organ failure.
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(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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