IVC Filter Manufacturers and Issues

By: LawInfo

Inferior vena cava (IVC) filter lawsuits have received increased attention for injuries and medical complications. More than 300 lawsuits have sprung up across the country, featuring allegations of:

  • Device fracturing, breaking, and migration
  • Perforation of the IVC
  • Device failure to capture blood clots from entering the heart and lungs
  • Clot formation around the device

Injuries and infections around the areas where the implanting catheter was inserted

Cook Medical and CR Bard's IVC devices have been the target of most of the recent lawsuits. However, there are many other companies manufacturing similar devices. There have been more than 15 IVC filter models used in the United States and two to three updates of a few models.

This article is an overview of device manufacturers and their IVC filters. All have either been the target of litigation or were reported as potentially problematic by medical professionals.

Cook Medical

Number of Devices on Market: 3

Cook, an Indiana medical device manufacturer, produces three retrievable IVC filter models of varying design:

  • The Celect Vena Cava Filter was granted 501(k) premarket clearance by the FDA in 2007 for permanent use. In 2008 it was cleared for retrievable use. 501(k) clearance is granted by the FDA to new or updated medical devices that classify under three device categories. If a device is similar to any others within its class, it's approved for sale on the medical market. This filter is designed for short- and long-term implantation. On Market: Yes
  • The Günther Tulip Vena Cava Filter was granted 501(k) clearance in 2000 for permanent use and in 2003 for retrievable use. This filter is designed for short- and long-term implantation. On Market: Yes
  • The Gianturco-Roehm Bird's Nest Vena Cava Filter was granted 501(k) clearance in 1989. This filter is designed for permanent implantation. On Market: Yes

All three filters face allegations like device migration, fracturing, and perforation. More than 280 complaints against these filters have been consolidated into a multidistrict litigation (MDL) at the U.S. District Court of the Southern District of Indiana.

CR Bard

Number of Devices on Market: 6

Bard, a New Jersey medical technology manufacturer, produces a number of retrievable and permanent IVC filter models:

  • The Recovery Filter System was granted 501(k) clearance in 2002 for permanent use and for optional use in 2003. This filter was designed for short-term implantation. On Market: No
  • The G2 Vena Cava Filter was granted 501(k) clearance in 2005. This filter is designed for short- and long-term implantation despite its clearance for permanent implantation only. On Market: Yes
  • The G2X (a.k.a. the G2 Express) Vena Cava Filter was granted 501(k) clearance in 2008. This filter is designed for short- and long-term implantation. On Market: Yes
  • The Eclipse Vena Cava Filter was granted 501(k) clearance in 2010. This filter is designed for short- and long-term implantation. On Market: Yes
  • The Meridian Vena Cava Filter was granted 501(k) clearance in 2011. This filter is designed for short- and long-term implantation. On Market: Yes
  • The Denali Vena Cava Filter was granted 501(k) clearance in 2013. This filter is designed for short- and long-term implantation. On Market: Yes
  • The Simon Nitinol Vena Cava Filter was granted 501(k) clearance in 1990. This filter is designed for permanent implantation. On Market: Yes

The G2, G2X, and Eclipse filters replaced the Recovery filter, which yielded many reports of device fracturing and migration. While they featured improvements over the original design, the second generation of filters also yielded similar reports.

The Meridian filter was manufactured with several design improvements to the G2 and Eclipse lines. However, an upgrade to the anchoring mechanisms may have created serious problems for retrieval. The Meridian filter may also still pose a fracturing risk.

More than 20 complaints against Bard IVC filters have been consolidated into an MDL at the U.S. District Court of the District of Arizona.

Boston Scientific

Number of Devices on Market: 1

Boston Scientific, a Massachusetts medical device manufacturer, produces only one permanent IVC filter:

  • The Greenfield Vena Cava Filter received 501(k) clearance in 1989. This filter is designed for short- and long-term implantation. On Market: Yes

The Greenfield IVC filter allegedly has suffered from many of the issues seen with Bard and Cook filters, including device migration and fracturing. It faces several complaints from injured patients including the wrongful death of Cinthia Ratliff. Ratliff was implanted with a Greenfield filter in 2004 to treat deep vein thrombosis and died in 2013 from a perforated IVC.

The filter was also recalled by Boston Scientific in 2004 due to a risk of pulmonary embolism during implantation. The recall did not affect devices already implanted in patients.

Rex Medical

Number of Devices on Market: 1

Rex, a Pennsylvania medical device manufacturer, produces only one retrievable IVC filter:

  • The OptionELITE Retrievable Vena Cava Filter received 501(k) clearance in 2013. This filter is designed for short- and long-term implantation. On Market: Yes

The Rex OptionELITE filter may pose risks of device migration and fracturing according to adverse event reports submitted to the FDA.

B. Braun Interventional Systems

Number of Devices on Market: 2

Braun, a Pennsylvania medical device manufacturer, markets three models of permanent IVC filters in the U.S.:

  • The VenaTech Convertible Vena Cava Filter System was granted 501(k) clearance in 2016. This filter is designed for permanent implantation with a convertible option. When the risk of pulmonary embolism has subsided, the filter can be converted into an "open" position that allows for free blood flow through the IVC. On Market: Yes
  • The VenaTech LGM Vena Cava Filter System was granted 501(k) clearance in 1989. This filter was designed for permanent implantation. On Market: No
  • The VenaTech LP Vena Cava Filter System was granted 501(k) clearance in 2001. This filter is designed for permanent implantation. On Market: Yes

The VenaTech LP IVC filter replaced the VenaTech LGM filter due to the LGM’s high incidence of "incomplete deployment." Note that the LP filter allegedly continues to exhibit the same problem. The LP filter also allegedly has device migration issues due to a design flaw. It seems that flaw causes its anchoring "legs" to become stuck upon deployment.

These issues have only been reported to the FDA and not in any court documents. Thus far, no lawsuits or complaints against Braun's IVC filters have been filed in the U.S.

ALN Implants Chirurgicaux

Number of Devices on Market: 1

ALN, a French IVC filter manufacturer, produces only one retrievable filter:

  • The ALN Optional Vena Cava Filter with Hook received 501(k) clearance in 2008. This filter is designed for short- and long-term implantation. On Market: Yes

The ALN IVC filter has been involved in only five medical complications reported to the FDA. The most common issues associated with it are device migration and failure to deploy. No lawsuits have been filed against the ALN filter yet.

Cordis Corporation

Number of Devices on Market: 2

Cordis, a Florida medical device manufacturer, produces two permanent and retrievable IVC filters:

  • The TRAPEASE Permanent Vena Cava Filter received 501(k) clearance in 2000. On Market: Yes
  • The OPTEASE Retrievable Vena Cava Filter received 501(k) clearance in 2002 for permanent use and in 2004 for retrievable use. On Market: Yes

According to a Japanese study, the TRAPEASE filter presented a high incidence of device fracturing, which allegedly caused internal injuries as the fragments traveled through the patients' bloodstream.

In 2013, the FDA issued a Class I recall for the OPTEASE filter due to problems with the product's labeling that caused surgeons to implant the filter backwards. The Class I recall indicates that the issues with the OPTEASE filter posed unnecessarily serious or fatal health risks for patients. No complaints against Cordis IVC filters have been filed yet.

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