The manufacturer is reporting this event in a conservative manner due to the device malfunction (structural valve deterioration) identified prior to the patient's death.However, at this time there is no further information available on the device functionality over time, treatment provided, and device relationship with the patient's death.Further investigation is ongoing and an update will be provided should further information be received.
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Fields updated: b4, f6, f7.The manufacturer attempted to retrieve additional information on the event, but no further information has been received to date despite the attempts.As the device was not returned for analysis and the serial number remains unknown, no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.Structural valve deterioration is included as a possible adverse event in the perceval ifu.Thus, the event is a known inherent risk of the device.Since no further information was provided on the event, patient's clinical history, device functionality over time, the root cause of the event and the relationship between the perceval valve with the patient's death cannot be definitively stated.Should further information be provided in the future, the manufacturer will re-assess the event and provide an update to this reporting activity.
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