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) 2017, a 27mm masters series valve was implanted in the mitral position.On (b)(6) 2017, the patient reported with dyspnea.An obstructed leaflet was reported to be the cause.Per report on (b)(6) 2017, the masters series valve was explanted and replaced with an unknown valve on (b)(6) 2017.The patient is reported to have died 4 days later of an unknown cause.Additional details were requested.
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