365 - Symptomatic and Life-Threatening Adverse Events for IVC Filters Are More Likely to Be Related to Older Shelf Life Products: A MAUDE Database Analysis

Purpose: Inferior vena cava (IVC) filters carry risks of delayed complications; while increased dwell time is known to worsen outcomes, the role of device shelf life remains poorly defined. This study evaluates whether filters implanted later in their shelf life are associated with higher rates of symptomatic or severe adverse events.

Materials and Methods: A retrospective review of the FDA MAUDE database identified 34,372 IVC filter adverse event reports reported since April 2019. Reports with both manufacture and event dates were analyzed (n=759) across a 3-year follow up period.

Results: Among 759 reports, mean patient age was 53.0 years, and 50.4% were female. Severe outcomes (life-threatening or death) occurred in 26.7%, and 35.3% required reintervention. Thrombosis/occlusion (n=195) and cardiovascular injury (n=170) were most frequently life-threatening (57.9% and 20.6%) patient problems. Malposition (n=280) and deployment/removal complications (n=257) were most common device issues, each linked to life-threatening outcomes in 21–26% of cases. Symptomatic events (n=449) occurred later post-manufacture than asymptomatic events (median 242 vs. 190 days, p< 0.0001). Life-threatening events (n=197) also occurred later than less severe outcomes (328 vs. 195 days, p< 0.0001). Devices implanted later in shelf life showed higher rates of symptomatic and severe complications, with variability across brands. Adverse events for nitinol filters occurred significantly later than those constructed of conichrome (242 days vs. 145 days, p < 0.0001). Nitinol devices were more frequently associated with vascular, thrombotic, and pain-related symptoms compared to conichrome devices (p < 0.0001). Patients with conichrome devices were more often asymptomatic (p < 0.0001). There were no significant differences in hemodynamic or respiratory symptoms (p = 0.4463 and p = 1.0000, respectively).

Conclusion: IVC filter adverse events with symptomatic or life-threatening outcomes are more common when devices are implanted later in shelf life and device material influences both the timing and severity of these adverse events. Device age should be considered in clinical decision making as an underappreciated risk factor for severe complications.