Comparison of complication rates associated with permanent and retrievable inferior vena cava filters: a review of the MAUDE database.

PURPOSE

To compare the safety of permanent and retrievable inferior vena cava (IVC) filters by reviewing the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.

MATERIALS AND METHODS

The MAUDE database was reviewed from January 1, 2009, to December 31, 2012. Product class search criteria were "filter, intravascular, cardiovascular." Type of device used and specific adverse events (AEs) were recorded.

RESULTS

For the period January 2009-December 2012, 1,606 reported AEs involving 1,057 IVC filters were identified in the MAUDE database . Of reported AEs, 1,394 (86.8%) involved retrievable inferior vena cava filters (rIVCFs), and 212 (13.2%) involved permanent inferior vena cava filters (pIVCFs) (P < .0001). Reported AEs included fracture, migration, limb embolization, tilt, IVC penetration, venous thromboembolism and pulmonary embolism, IVC thrombus, and malfunctions during placement. Each specific AE was reported with significantly higher frequency in rIVCFs compared with pIVCFs. The most common reported complication with rIVCFs was fracture, whereas the most commonly reported complications with pIVCFs were placement malfunctions. For rIVCFs, the most commonly reported AE varied depending on filter brand.

CONCLUSIONS

The MAUDE database reveals that complications occur with significantly higher frequency with rIVCFs compared with pIVCFs. This finding suggests that the self-reported complication rate with rIVCFs is significantly higher than the self-reported complication rate with pIVCFs.