Structural Mechanics Predictions Relating to Clinical Coronary Stent Fracture in a 5 Year Period in FDA MAUDE Database

Abstract

Endovascular stents are the mainstay of interventional cardiovascular medicine. Technological advances have reduced biological and clinical complications but not mechanical failure. Stent strut fracture is increasingly recognized as of paramount clinical importance. Though consensus reigns that fractures can result from material fatigue, how fracture is induced and the mechanisms underlying its clinical sequelae remain ill-defined. In this study, strut fractures were identified in the prospectively maintained Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), covering years 2006–2011, and differentiated based on specific coronary artery implantation site and device configuration. These data, and knowledge of the extent of dynamic arterial deformations obtained from patient CT images and published data, were used to define boundary conditions for 3D finite element models incorporating multimodal, multi-cycle deformation. The structural response for a range of stent designs and configurations was predicted by computational models and included estimation of maximum principal, minimum principal and equivalent plastic strains. Fatigue assessment was performed with Goodman diagrams and safe/unsafe regions defined for different stent designs. Von Mises stress and maximum principal strain increased with multimodal, fully reversed deformation. Spatial maps of unsafe locations corresponded to the identified locations of fracture in different coronary arteries in the clinical database. These findings, for the first time, provide insight into a potential link between patient adverse events and computational modeling of stent deformation. Understanding of the mechanical forces imposed under different implantation conditions may assist in rational design and optimal placement of these devices.

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

“…Previous studies have used MAUDE data to analyze a variety of medical technology malfunctions, from coronary stent fracture (14) to health information technology (15–17). However, there are no previous studies using MAUDE data on therapeutic radiation devices.…”

Differences in rotational positioning and subsequent distal main branch rewiring of the Tryton stent: An optical coherence tomography and computational study

“…Areas of high stent stresses are associated with stent strut fractures . However, the fenestration of the panel in the rewiring “through a panel” scenario did not lead to excessive peak stresses of the stent.…”

Sex differences in the outcomes of stent implantation in mini-swine model

“…Different hemodynamic patterns could potentially influence the outcomes of stent implantation. In the pooled data, the stents were implanted in all three coronary arteries and we and others have shown differential physical forces and hemodynamic patterns on the different coronary arteries [ 49 ]. Although statistical analysis could not be performed by subcategorizing our analysis by each coronary artery due to the limited sample size, no difference was observed in neointima area, restenosis rate, or any histomorphological parameters among three coronary arteries.…”