Table 3

Types of Adverse Events Reported to the MAUDE Database Between January 1, 2002 and June 30, 2007

Adverse EventPercentage of Reported Events for 18,333 (Estimated) Implants
Device embolization51
Cardiac perforations23
Thromboembolic complications5
Residual/recurrent defect4
Device infection2

Reprinted, with permission, from DiBardino et al. (18).

MAUDE = Manufacturer and User Facility Device Experience.