Jessica M Andreoli1, Robert J Lewandowski1, Robert L Vogelzang1, Robert K Ryu2. 1. Department of Radiology, Section of Interventional Radiology, Northwestern University, 676 North St Clair Street, Ste 800, Chicago, IL 60611. 2. Department of Radiology, Section of Interventional Radiology, Northwestern University, 676 North St Clair Street, Ste 800, Chicago, IL 60611. Electronic address: Robert.Ryu@ucdenver.edu.
Abstract
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. Published by Elsevier Inc.
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. Published by Elsevier Inc.
Authors: Steven Y Huang; Bruno C Odisio; Sharjeel H Sabir; Joe E Ensor; Andrew S Niekamp; Tam T Huynh; Michael Kroll; Sanjay Gupta Journal: J Thromb Thrombolysis Date: 2017-07 Impact factor: 2.300
Authors: Jennifer K Karp; Kush R Desai; Riad Salem; Robert K Ryu; Robert J Lewandowski Journal: Semin Intervent Radiol Date: 2016-06 Impact factor: 1.513