Health Canada Issues IVC Filter Warning

Health Canada Issues IVC Filter Warning

Posted By Maher Law Firm || 25-Jul-2016

The FDA has issued a number of warnings in connection with IVC filter devices manufactured by C.R. Bard and Cook Medical. Today, Health Canada has also posted a product safety warning regarding these dangerous medical devices. Since June of 2016, Health Canada has received 121 incident reports of serious complications associated with IVC filter devices, which are small, cage-like metal devices designed to be implanted into the inferior vena cava (IVC) in order to catch blood clots before they can travel to the lungs. While helpful for some patients, use of these devices has been linked with widespread reports of IVC perforation, lower limb deep vein thrombosis, filter fracture and fragment embolization, cardiac perforation, intracardiac migration, cardiac tamponade, and death. The majority of these complications resulted from device implantation lasting longer than 30 days.

Created as a way to prevent pulmonary embolism in patients for which anticoagulation therapy is unsuitable, IVC filters may cause more harm than good. When left in the body for longer than intended, the device may move from its original location to other areas of the body, or may break and send sharp pieces of metal through the vein leading to the heart. The result can be serious, painful injury requiring additional surgeries and, in severe cases, may result in the death of the patient. Removing the devices from patients has proven to be a challenge in many cases.

Health Canada identifies the following affected products:

  • A.L.N.
    • ALN Vena Cava Filter
  • Bard Peripheral Vascular
    • Denali Vena Cava Filter
    • G2 Filter System
    • Simon Nitinol Vena Cava Filter
  • B. Braun Medical
    • VenaTech LP Vena Cava Filter System
  • Cordis Cashel
    • Optease Vena Cava Filter
    • Trapease Permenent Vena Cava Filter
  • REX Medical, LP
    • Option Retrievable Vena Cava Filter System
  • William Cook, Europe APS and Cook, Inc.
    • Cook Celect Platinum Vena Cava Filter
    • Cook Celect Vena Cava Filter
    • Gianturco-Roehm Birds Nest Vena Cava Filter
    • Gunther Tulip Vena Cava MREye Filter Set

Health Canada reminds doctors that IVC devices are intended for short-term use and that, when possible, they should be removed as soon as anticoagulation therapy can safely begin. Hospitals are encouraged to identify all patients who have received a retrievable device so that a formal strategy for filter removal can be formulated.

If you have received an IVC filter in the U.S. and have suffered harm, you have a right to speak with a lawyer about your options for legal recourse. The Maher Law Firm is now accepting nationwide IVC cases and is prepared to offer you a free consultation. Call us today to talk about your potential case.

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