Trends in FDA Adverse Events Reporting for Inferior Vena Cava Filters and Estimated Insertions in the US, 2016 to 2020

Abstract

This quality improvement study identifies adverse events for inferior vena cava filters and reports changes in adverse event reporting and estimated insertions between 2016 and 2020 in the US.

To prevent potentially fatal pulmonary emboli, inferior vena cava filters (IVCFs) are implanted in patients with venous thromboembolism and contraindications to anticoagulation. A systematic review and meta-analysis of 6 randomized clinical trials of IVCFs found slightly decreased rates of pulmonary embolism, increased rates of deep vein thrombosis, and no changes in mortality.¹ The use of IVCFs has expanded, such as for venous thromboembolism prophylaxis in bariatric surgery.^1,2 In 2010, a study identified IVCF-associated harms, including filter fractures, embolization, and deaths.³ Publication prompted an immediate US Food and Drug Administration (FDA) safety advisory noting there had been nearly 1000 IVCF adverse event (AE) reports and reminded physicians to remove devices that could be retrieved.⁴

Despite limited data of clinical benefit, IVCF implantation rates remain high in the US, and retrieval rates, although increasing, remain low (7%-22%).⁵ We studied trends in IVCF AE reporting and estimated insertions in the US.

Methods

In this quality improvement study, we used Device Events to identify IVCF AE reports received by the FDA between January 1, 2016, and December 31, 2020. Device Events is a proprietary software that exports data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to an interface that can be used to navigate the database, as previously described.⁶ This study was exempt from institutional review board approval because it did not include patient information. The software uses a natural language processing algorithm to identify reports in which a death or serious harm may have occurred (eMethods in Supplement 1). We used Medicare fee-for-service claims data from 2016 to 2020 to estimate annual IVCF insertion volume, including patients receiving and not receiving Medicare (eMethods in Supplement 1). We calculated the annual numbers of AE reports, serious harms, and IVCF insertions, and used negative binomial regression to assess changes between years. Statistical significance was taken as P < .05.

Results

From 2016 to 2020, we identified 9311 AE reports for IVCFs, which increased from 1020 in 2016 to 2842 in 2020, or by a factor of 1.26 (95% CI, 1.15-1.37; P < .001) annually (Figure 1). Of the reports, 5968 (64.1%) were classified as patient injury, 2958 (31.8%) as device malfunction, 377 (4.0%) as death, and 8 (0.1%) as not categorized. The most commonly coded patient problem was perforation (3178 [34.1%]), including perforation of vessels (2330 [25.0%]), internal organs (855 [9.2%]), and/or great vessels (372 [4.0%]). The second most commonly listed problem was no consequence (3146 [33.8%]). Reports often listed more than 1 patient problem. Overall, 519 reports (5.6%) contained language indicating serious patient harm or death, increasing by a factor of 1.11 (95% CI, 1.04-1.18; P = .001) annually (from 81 in 2016 to 125 in 2020) (Figure 2).

Figure 1. Inferior Vena Cava Filter (IVCF) Adverse Event Reports (AERs), 2016 to 2020.

Annual number of IVCF AERs to the US Food and Drug Administration Manufacturer and User Facility Device Experience database by report type.

Figure 2. Estimated Inferior Vena Cava Filters (IVCFs) Inserted and Adverse Event Reports, 2016 to 2020.

Estimated number of IVCFs inserted annually and number of IVCF adverse event reports, including reports containing death or serious harms.

From 2016 to 2020, estimated US IVCF insertions decreased by a factor of 0.89 (95% CI, 0.89-0.90; P < .001) annually (from 71 778 to 44 778) (Figure 2). The proportion of reports indicating death or serious harm increased by a factor of 1.25 (95% CI, 1.17-1.33; P < .001) annually (from 0.11% [95% CI, 0.0009-0.0014] in 2016 to 0.28% [95% CI, 0.0023-0.0033] in 2020).

Discussion

From 2016 to 2020, there was a sustained increase in the annual number of AE reports to the FDA for IVCFs, and a sustained decrease in the estimated number of IVCF insertions in the US. The increased number of AE reports may reflect the increase in device fracture risk over time, if indwelling filters are not retrieved. It is unknown the extent to which the increased number of reports reflects improved reporting or an actual increase in the number of AEs. The estimates of annual IVCF insertions are limited by the lack of publicly available sales data and of non-Medicare claims data. Additionally, MAUDE data are subject to underreporting of AEs. Given the limited evidence of clinical benefit and the potential explanations for the trend data notwithstanding, the increasing number of US AE reports for IVCF warrants further study.

Supplement 1.

eMethods. Supplemental Methods Appendix

eReferences

Supplement 2.

Data Sharing Statement