Print this pageComplications and Outcomes Associated With the Use Of Retrievable Vena Cava Filters: A Review Of the Manufacturer and User Facility Device Experience Database (MAUDE) Database
Felix G Vladimir, Palma Shaw, Jeffery J Popma, Garry Gibbons
BOSTON UNIVERSITY, Boston, MA
Introduction and objectives:
The use of retrievable vena cava filters have replaced non-retrievable vena cava filters, but the frequency of complications using these new filters in clinical practice is not known.
The objective was to determine the complication rate associated with the use of retrievable filters reported in the FDA sponsored Manufacturer and User Facility Device Experience (MAUDE) database over a two-year period.
Methods:
We reviewed the MAUDE database between October 23, 2002 and December 22, 2004 and identified 282 reported cases associated with vena cava filters and coded for filter migration, perforation, vascular hematoma, filter and strut fractures, IVC thrombosis, and pulmonary embolism. Outcomes included death, surgical or percutaneous removal of the device, and the requirement for additional filters. Because the overall frequency of device use was not known, cross-device comparisons cannot be made.
Results:
Migration of the filter was the most frequently reported event with the BARD Recovery Filter (49.2%) and the Cordis Trapese(Optese) Filter (20.0%) whereas failure to deploy was the most commonly reported complication associated with the use of the Greenfield Filter (71.1%) and Gunther Tulip device (44.4%). Fractures were reported with the nitinol Recovery (31.7%) and Trapese(Optese) (15%) filters. Strut migration was also reported with the Recovery device (31.7%). IVC thrombosis was reported with the Trapese (Optese) device (18.5%), potentially attributable to the unique geometry of the device. Death was reported in 9.9% of all cases. Filters were either removed percutaneously (17.7%) or surgically (40.4%).
Conclusions:
We conclude that complications report within MAUDE database vary with the different retrievable and non-retrievable filters. These device specific complications may provide unique insights into the indications and recommendations for use of these devices in real world clinical practice.