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 abbott 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, a 23 mm trifecta valve was implanted.On (b)(6) 2016, the patient was hospitalized for endocarditis of the valve and on (b)(6) 2016, the valve was explanted and replaced with an unknown valve.
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