PMID- 24928649
OWN - NLM
STAT- MEDLINE
DCOM- 20150415
LR  - 20220321
IS  - 1535-7732 (Electronic)
IS  - 1051-0443 (Linking)
VI  - 25
IP  - 8
DP  - 2014 Aug
TI  - Comparison of complication rates associated with permanent and retrievable 
      inferior vena cava filters: a review of the MAUDE database.
PG  - 1181-5
LID - S1051-0443(14)00451-5 [pii]
LID - 10.1016/j.jvir.2014.04.016 [doi]
AB  - 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.
CI  - Published by Elsevier Inc.
FAU - Andreoli, Jessica M
AU  - Andreoli JM
AD  - Department of Radiology, Section of Interventional Radiology, Northwestern 
      University, 676 North St Clair Street, Ste 800, Chicago, IL 60611.
FAU - Lewandowski, Robert J
AU  - Lewandowski RJ
AD  - Department of Radiology, Section of Interventional Radiology, Northwestern 
      University, 676 North St Clair Street, Ste 800, Chicago, IL 60611.
FAU - Vogelzang, Robert L
AU  - Vogelzang RL
AD  - Department of Radiology, Section of Interventional Radiology, Northwestern 
      University, 676 North St Clair Street, Ste 800, Chicago, IL 60611.
FAU - Ryu, Robert K
AU  - Ryu RK
AD  - 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.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20140611
PL  - United States
TA  - J Vasc Interv Radiol
JT  - Journal of vascular and interventional radiology : JVIR
JID - 9203369
SB  - IM
MH  - Databases, Factual
MH  - Device Removal/*adverse effects
MH  - Foreign-Body Migration/etiology
MH  - Humans
MH  - Postoperative Complications/*etiology
MH  - Prosthesis Design
MH  - Prosthesis Failure
MH  - Prosthesis Implantation/*adverse effects/*instrumentation
MH  - Risk Factors
MH  - Thromboembolism/etiology
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vascular System Injuries/etiology
MH  - Vena Cava Filters/*adverse effects
EDAT- 2014/06/15 06:00
MHDA- 2015/04/16 06:00
CRDT- 2014/06/15 06:00
PHST- 2014/02/14 00:00 [received]
PHST- 2014/04/08 00:00 [revised]
PHST- 2014/04/19 00:00 [accepted]
PHST- 2014/06/15 06:00 [entrez]
PHST- 2014/06/15 06:00 [pubmed]
PHST- 2015/04/16 06:00 [medline]
AID - S1051-0443(14)00451-5 [pii]
AID - 10.1016/j.jvir.2014.04.016 [doi]
PST - ppublish
SO  - J Vasc Interv Radiol. 2014 Aug;25(8):1181-5. doi: 10.1016/j.jvir.2014.04.016. 
      Epub 2014 Jun 11.