Annals of Biomedical Engineering

, Volume 44, Issue 2, pp 391–403 | Cite as

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

  • Kay D. Everett
  • Claire Conway
  • Gerard J. Desany
  • Brian L. Baker
  • Gilwoo Choi
  • Charles A. Taylor
  • Elazer R. Edelman
Medical Stents: State of the Art and Future Directions

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.

Keywords

Stent fracture Arterial deformation Finite element analysis 

Supplementary material

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Copyright information

© Biomedical Engineering Society 2016

Authors and Affiliations

  • Kay D. Everett
    • 1
  • Claire Conway
    • 1
  • Gerard J. Desany
    • 2
  • Brian L. Baker
    • 2
  • Gilwoo Choi
    • 3
  • Charles A. Taylor
    • 3
  • Elazer R. Edelman
    • 1
    • 4
  1. 1.Institute for Medical Engineering and ScienceMITCambridgeUSA
  2. 2.Winchester Engineering and Analytical CenterUS Food and Drug AdministrationWinchesterUSA
  3. 3.Department of BioengineeringStanford UniversityStanfordUSA
  4. 4.Cardiovascular Division, Brigham and Women’s HospitalHarvard Medical SchoolBostonUSA

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