Cook IVC Filter
The Cook Gunther Tulip IVC filter was first made available in the United States in 2003. This IVC filter has four anchoring struts for fixation and eight independent secondary struts to improve clot trapping and centering of the device.
The Cook Gunther Tulip IVC filter is an optionally-retrievable IVC filter. Once the risk of clotting has passed, it should be removed from the patient. After 3 to 4 months, the filter is susceptible to breaking or moving in the body, which can lead to serious complications and even death for the patient.
Notably, in 2010, the FDA released a Safety Communication warning about the dangers associated with failing to remove optionally retrievable IVC filters. During a five-year period, the FDA received 921 reports of a patient experiencing an adverse event involving IVC filters. A breakdown of the adverse events is below:
- 56 cases of filter fractures
- 328 cases of filter migrations
- 146 cases of detachment of the IVC components
- 70 cases of perforation
Not surprisingly, some of the patients had serious adverse outcomes as a result of these events.
For More Information on IVC Filters:
- American Bar Association. (2013). Federal Rule of Civil Procedure 26.
- Bouldry, Huff, Lorenz and Roberts vs. Bard. (2012). 15th Judicial Circuit, Palm Beach County, Florida. Class action complaint for medical monitoring.
- Carr v. C. R. Bard. (2014). Case No. 3:13 CV 824. Memorandum opinion and order
- Cleveland Clinic. (2014). Inferior vene cava (IVC) filter retrieval. Retrieved from:https://my.clevelandclinic.org/services/heart/services/vascular_surgery/ivc-filter-retrieval
- Davis v. C.R. Bard. (2012). U.S. District Court Eastern District of Michigan Southern Division. Order granting in part and denying in part defendants’ motion for summary judgement. Retrieved from:https://www.gpo.gov/fdsys/pkg/USCOURTS-mied-2_11-cv-12556/pdf/USCOURTS-mied-2_11-cv-12556-0.pdf
- Deleon and Gonzalez. (2012). Class complaint for medical monitoring; Demand for trial by jury. Superior Court of the State of California for the County of Los Angeles – Central District.
- Ebert v. C. R. Bard (2014). U.S. District Court for the Eastern District of Pennsylvania. Memorandum. Retrieved from:https://casetext.com/case/ebert-v-cr-bard-1
- Johnson and Johnson v. Cook Medical. (2015). U.S. District Court Eastern District of Michigan Southern Division. Complaint and Demand for Jury Trial.
- Lehmann, J. (2004, December 15). Evaluation of MAUDE reporting rates, sales estimates and comparative bench testing related to vena cava filters.
- Brown and Brown vs. Bard. (2012). Class action complaint for medical monitoring. Court of Common Please Philadelphia County.
- Nicholson, W. et al. (2010, November 8). Prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. JAMA Internal Medicine, 170(20), 1,827-1,831. Retrieved from:https://archinte.jamanetwork.com/article.aspx?articleid=226212
- Sandler, T. Naggiar, S., & Gosik, S. (2015, September 3). Did blood-clot filter used on thousands of Americans have fatal flaw? NBC News. Retrieved from:https://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536
- Sandler, T. Naggiar, S., & Gosik, S. (2015, September 4). Did forged signature clear way for dangerous blood-clot filter?. NBC News. Retrieved from:https://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246
- Shayna, S., Crowther, M., & Sloan, M. (2013). Indications, complications, and management of inferior vena cava filters: The experience in 952 patients at an academic hospital with a level 1 trauma center. JAMA Internal Medicine, 173(7), 513-517. Retrieved from:https://archinte.jamanetwork.com/article.aspx?articleid=1669107
- Tillman vs. C. R. Bard. (2013). U.S. District Court Middle District of Florida Jacksonville Division. Complaint for damages.
- U.S. District Court Southern District of Indiana. (2015). MDL Case Information. Retrieved from:https://www.insd.uscourts.gov/mdl-case-information
- U.S. Food and Drug Administration. (2010, August 9). Removing retrievable inferior vena cava filters: Initial communication. Retrieved from:https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm
- U.S. Food and Drug Administration. (2014, May 6). Removing retrievable inferior vena cava filters: FDA safety communication. Retrieved from:https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm
- U.S. Judicial Panel on Multidistrict Litigation. (2014, October 15). Transfer Order MDL No. 2570. Retrieved from:https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2570-Initial_Transfer-10-14.pdf
- U.S. Judicial Panel on Multidistrict Litigation. (2015, August 17). Transfer Order MDL No. 2641. Retrieved from:https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2641-Initial_Transfer-07-15.pdf
- Vlasvich vs. C.R. Bard. (2013). U.S. District Court for the Northern District of Illinois. Complaint.