Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (12): 740-744.

• Orignal Article • Previous Articles     Next Articles

Analysis on the Common Risk Factors of Coronary Stent

ZHOU Ding-jie1, 2, ZHAO Yan3*, ZHOU Jing-xin4   

  1. 1 Jiangsu Institute of Planned Parenthood Research, Jiangsu Nanjing 210036, China;
    2 NCFPC Center for Contraceptives Adverse Reactor Surveillance, Jiangsu Nanjing 210036, China;
    3 Center for Drug Reevaluation, SFDA, Beijing 100045, China;
    4 Harbin Center for ADR Monitoring, Heilongjiang Harbin 150016, China
  • Received:2012-08-29 Online:2012-12-10 Published:2015-08-07

Abstract: Objective To explore the risk point of coronary stent adverse events and offer the risk control measures respectively. Methods A total of 108 cases of coronary stent adverse events were collected from the domestic literature and analyzed retrospectively. Results The primary lesions of coronary stent adverse events were grouped into three categories: the intraoperative and postoperative secondary diseases, the device operated differently than expected or device malfunction, the signs and symptoms after stent implanted. The most common event consequence was needed for internal, surgical treatment to avoid permanent damage to the body structure. Conclusion The injury of stent thrombosis was the most severe and the in-stent restenosis was the most common risk point in all of the coronary stent adverse events. The control measures should be taken at same time by the manufacturing enterprises of medical device, the medical institutions and the supervision departments to decrease the risk of coronary stent in clinic.

Key words: percutaneous coronary intervention, coronary stent, medical device adverse event, stent thrombosis, in-stent restenosis