Fields updated: b4, g3, g9, h1, h2 (indicated as a placeholder, no new information received), h6.The manufacturer attempted to retrieve additional information on the event and the device involved, but no further information has been received to date.Since the device was not returned for investigation (reasonably still implanted) and since the serial number is 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.Since endocarditis was suspected, it is possible that the increase of the gradient and the leaflet hypomobility are secondary to this clinical event.However, since the baseline patient's conditions, device functionality over time and final diagnosis and treatment provided are unknown, the root cause cannot be established at this time.Should the manufacturer receive additional information, an update to this reporting activity will be provided.
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