Reports of Coronary Stent Fracture from the Food and Drug Administration Manufacturer and User Facility Device Experience Database, 2013-2018

Background:
Coronary stent fracture (SF) is known to be associated with complications such as restenosis and stent thrombosis. A review of device-related safety issues reported to the Food and Drug Administration and captured in the Manufacturer and User Facility Device Experience (MAUDE) database from 2005 to July 2013 found that more than 80% of all coronary SF cases involved first generation stents. Advancements in stent materials and design in recent years have improved the safety and effectiveness of coronary stents, however, contemporary data on SF are lacking.

Methods:
The MAUDE database was analyzed for cases of coronary SF between August 2013 and August 2018. Procedure-related SFs and reports derived from publications were excluded. Details of SF cases, including clinical presentation of SF, lesion characteristics, type of stent, and management of SF were extracted from the MAUDE records.

Results:
A total of 30 cases of coronary SF were identified. Clinical presentation was chest pain for 43.3% of cases; another 13.3% were diagnosed with unstable angina or myocardial infarction. The most commonly affected vessel was the left anterior descending artery (26.7% of SF cases), followed by the right coronary artery (20% of SF cases). One SF case involved a bare metal stent; 23.3% of SF cases involved first generation drug-eluting stents (DES); the remaining 76.7% of SF cases involved second generation or later DES. The majority of cases (63.3%) were managed with percutaneous coronary intervention; 6.7% of cases were managed with coronary artery bypass surgery.

Conclusions:
Reports of coronary SF in the MAUDE database have declined in recent years, primarily due to a decrease in first generation DES-related events. Clinical presentation of SF, affected vessels and management of SF cases were concordant with previous analyses.