The Cook Celect IVC Filter is an optionally-retrievable IVC filter with four anchoring struts for fixation and eight independent secondary struts to enhance centering and clot trapping.
A new study reveals a brand of IVC filter — a small, metal cage-like device used to prevent blood clots from entering the lungs — poses a significant risk of puncturing a major blood vessel.
The Cook Celect filter had a 43 percent rate of perforation versus the Option filter, which had a zero percent perforation rate. Study authors noted this was a “significantly higher rate.”
In the study published in June 2015 in the Journal of Vascular Interventional Radiology, researchers looked at the records of 99 people implanted with the Cook Celect IVC filter and 86 patients who received an Option filter sold by Rex Medical. After about two months, doctors retrieved the filters. While surgeons had slightly more difficulty retrieving Option filters from the vein, the difference in the rate of retrieval was negligible.
Researchers were more concerned with a potentially troublesome complication: vena cava perforation. Surgeons place IVC filters in the inferior vena cava, the large vein that carries blood back to the heart. The filters are designed with small prongs called struts that act like a cage for blood clots. Unfortunately, some devices also puncture, or perforate, the vena cava wall.
The Cook Celect IVC filter was first introduced in 2008 after receiving 510(k) clearance from the FDA. FDA 510(k) clearance permits a manufacturer to market a medical device quicker and without the necessity of a more in-depth premarket approval (PMA). To qualify for 510(k) clearance, the new medical device must be “substantially equivalent” to an already approved medical device. In the case of the Cook Celect IVC filter, the substantially equivalent product was the Cook Gunther Tulip IVC filter and so the Cook Celect IVC filter went to market without formal review for the safety and efficacy of the device.
Studies of the Cook Celect IVC filter have shown multiple problems. In short, the filter cannot withstand the normal anatomical and physiological loading cycles exerted in the body as blood is circulated to and from the heart. A study of Gunther Tulip and Celect IVC filters implanted from 2007 to 2009 showed 100% of the Celect and Gunther Tulip IVC filters had some degree of filter perforation of the vein wall within 71 days after surgery. The same study showed that 40% of the Celect and Gunther Tulip IVC filters were out of position or tilted.
For more information on IVC Filters, visit:
- American Bar Association. (2013). Federal Rule of Civil Procedure 26. Retrieved from:https://www.americanbar.org/content/dam/aba/administrative/litigation/materials/2013_jointcle/7_2_federal_rule_civil_procedure_26.authcheckdam.pdf
- 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. Retrieved from:https://www.resourcefullaw.com/documents/10162/0/CARR+v+C+R+BARD.pdf
- 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. Retrieved from:https://msnbcmedia.msn.com/i/MSNBC/Sections/NEWS/lehmann.pdf
- 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.