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:
Bard Peripheral Vascular
- Denali Vena Cava Filter
- G2 Filter System
- Simon Nitinol Vena Cava Filter
B. Braun Medical
- VenaTech LP Vena Cava Filter System
- 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.