Coronary Stent Fracture: Clinical Evidence Vs. the Testing Paradigm.

PURPOSE: The United States' Food and Drug Administration (FDA) recommends that device manufacturers demonstrate 10 years of equivalent life duration for endovascular stents. Yet since the early 2000s clinical evidence of stent strut fracture defies the recommendations for these FDA approved devices. Stent strut fracture has been correlated with a higher incidence of adverse clinical events, such as in-stent thrombosis and in-stent restenosis.

METHODS

This paper reviews the current clinical evidence, computational modelling relating to fatigue lifetimes, experimental testing of coronary stents, and the related regulatory guidance and standards.

RESULTS

The scale of stent fracture is evident from the clinical data reviewed. In terms of model setups, either physical or computational the loadings, in particular, dictate the durability response.

CONCLUSIONS

The full scale of stent fracture is most likely under-reported and its assessment is dependent on detection time and detection resolution. Within the event of SF it is not necessarily consequential; further research is warranted to distinguish when the event negatively impacts the patient.