title: Comparison of complication rates associated with permanent and retrievable inferior vena cava filters: a review of the MAUDE database.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, 676 North St Clair Street, Ste 800, Chicago, IL 60611.
authors.forename: Jessica M
authors.initials: JM
authors.lastname: Andreoli
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, 676 North St Clair Street, Ste 800, Chicago, IL 60611.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lewandowski
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, 676 North St Clair Street, Ste 800, Chicago, IL 60611.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Vogelzang
authors.affiliation: 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.
authors.forename: Robert K
authors.initials: RK
authors.lastname: Ryu
mesh_terms: D016208:Databases, Factual; D020878:Device Removal / Q000009:adverse effects*; D005548:Foreign-Body Migration / Q000209:etiology; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology*; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation*; D012307:Risk Factors; D013923:Thromboembolism / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D057772:Vascular System Injuries / Q000209:etiology; D016306:Vena Cava Filters / Q000009:adverse effects*