(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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On (b)(6) 2011, the patient underwent an aortic valve replacement procedure and this 25 mm sjm trifecta valve was implanted.On (b)(6) 2015, the patient was admitted with fever, rigors, and shortness of breath.Blood culture results were positive for streptococcus bovis.The patient's endocarditis was treated with antibiotics and was discharged on (b)(6) 2015.
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