On an unknown date, an unknown sized trifecta valve was implanted.On an unknown date, degeneration of the trifecta valve was reported and on an unknown date, the valve was explanted.On an unknown date, the patient passed away due to unknown causes, however the physician reported that the patient's passing was "not linked to the valve." additional information was requested, however was unavailable.
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Additional information sections: h2, h6, h10.The reported event of "degeneration" of the trifecta valve could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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