To answer your questions, yet, this is regarding a device that has already gone through a clinical trial; however, the hazardous situations I mention are only loosely based on the actual clinical risks. This is a device in which there is a lot of clinical data and information available from similar devices, standards, journal articles, etc. The rate of certain clinical events is known. It is a life saving device that is considered high risk because of adverse events associated with its use (in both fault and non-fault conditions). As the manufacturer, we are required to always consider these clinical adverse events when doing a risk/benefit analysis. There are some clinical events in which there is no way to reduce risk, but we still must justify them compared to the life-saving benefit and also compared to other similar devices.
These clinical events that occur under normal use would not be listed in any
FMEA. They would be listed in other risk analysis documentation though, and there are ways that some of the risks could be reduced. For example, if we discover that a certain set of the patient population has a much greater chance of developing a stroke. We may specifically exclude those patients from the target patient population. If a physician then decides to go ahead and implant the device in one of those patients, this would be considered off-label use.
I agree with Ronan in that for many of these clinical events we do the best we can when writing down the hazardous situations and estimating the probability of harm.