FDA: Vena Cava Filter Recall
On December 2nd, 2005, Boston Scientific Corporation announced that it was voluntarily recalling all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004 . This recall does not affect vena cava filters that have been implanted in patients.
The Company initiated this recall after a review of complaint records and analysis of returned devices revealed potential problems of detachment at the bond between the carrier capsule and the outer sheath of the filter's delivery system during the implant procedure. If the carrier capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolism.
A total of eight complaints were received, two of which were reported as involving serious patient injury and one was reported as a death. The total number of devices involved in this recall is estimated at 18,000.
Stainless Steel Greenfield Vena Cava Filters
A vena cava filter is a small cone-shaped, metallic device inserted into a major vein to prevent a blood clot from entering the lungs. The filter is implanted in the inferior vena cava - the large vein that carries blood from the lower part of the body to the heart. The filter prevents pulmonary embolism by capturing blood clots before they can be carried to the lungs. The blood clots are trapped in the filter while blood naturally flows both through and around the entrapped clot.
Insertion of a vena cava filter is an invasive procedure. The patient is prepared for this procedure using standard surgical protocols. The VCF is commonly implanted in the jugular vein in the neck or the femoral vein in the groin.
What Is Pulmonary Embolism?
A pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled from the leg to the lung. A clot that forms in one part of the body and travels in the bloodstream to another part of the body is called an embolus.
More than 600,000 people in the United States have a pulmonary embolism each year, and more than 60,000 of them die. Most of those who die do so within 30 to 60 minutes after symptoms start. Pulmonary embolism is one of the most common causes of death in hospitalized people who must remain in bed for a long time. Pulmonary embolism occurs equally in men and women.
The most common signs and symptoms of pulmonary embolism are:
- Unexplained shortness of breath
- Coughing up blood
- Anxiety or feelings of dread
- Lightheadedness
- Fainting
- Rapid breathing
- Increased heart rate
- Swelling or pain in legs
- Chest pain that gets worse with a deep breath, coughing, or chest movement
Pulmonary embolism is a serious condition that can cause:
- Permanent damage to part of the lung from lack of blood flow to lung tissue
- Low oxygen levels in the blood
- Damage to other organs in the body from lack of oxygen.
If a clot is large, or if there are many clots, pulmonary embolism can cause death.
In most cases, pulmonary embolism is a complication of a condition called deep vein thrombosis (DVT). In DVT, blood clots form in the deep veins of the body, most often in the legs. These clots can break free, travel to the lung, and block an artery.