Abstract
Purpose: We aimed to compare the safety of permanent (pIVC) and potentially retrievable (rIVC) inferior vena cava filters by reviewing the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. We hypothesize that self-reported complication rates respectively associated with rIVC and pIVC filters are equivalent. Materials and Methods: The MAUDE database was reviewed from January 1, 2009 to December 31, 2012. Product class search criteria were “filter, intravascular, cardiovascular.”. The total number of complications per year and complication type/rates were recorded for pIVC and rIVC devices. Binomial test was used for statistical analysis with rejection of the null hypothesis at po0.05. Results: 1,606 reported adverse events (AE) involving 1,057 IVC filters were identified. 1,394 (86.8%) AEs involved rIVC and 212 (13.2%) involved pIVC (po0.0001). The number and percentage of each specific AE was higher in rIVC compared to pIVC (see table). The most commonly reported AE varied depending on filter brand: fracture (27.1%) for Bard (Bard Peripheral Vascular, Tempe, AZ) devices, IVC penetration(29.9%) for Celect (Cook Medical, Bloomington, IN), placement difficulties for Optease (Cordis Endovascular, Warren, NJ) (30.8%) and Gunther Tulip (Cook Medical, Bloomington, IN) (45%). Conclusion: MAUDE database review reveals statistically significantly higher complication rate associated with rIVC compared to pIVC filters. Among rIVC filters prevalence of each specific complication varied widely among brands. This study suggests that optional filters are inferior to permanent devices in terms of self-reported, deviceassociated complications.
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