The Health Canada has issued a medical device alert concerning inferior vena cava (IVC) filters. The manufacturers, models and categories of the affected devices are as follows:
| Manufacturer | Model | Category |
|---|---|---|
| ‧A.L.N | ALN Vena Cava Filter | Retrievable |
| ‧Bard Peripheral Vascular | Denali Vena Cava Filter G2 Filter System Simon Nitinol Vena Cava Filter |
Retrievable Retrievable Permanent |
| ‧B. Braun Medical | VenaTech LP Vena Cava Filter System | Permanent |
| ‧Cordis Cashel | Optease Vena Cava Filter Trapease Permanent Vena Cava Filter |
Retrievable Permanent |
| ‧REX Medical, LP | Option Retrievable Vena Cava Filter System | Retrievable |
| ‧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 |
Retrievable Retrievable Permanent Retrievable |
As of June 6, 2016, Health Canada has received 121 incident reports of serious complications associated with IVC filters. These complications have also been reported internationally. Serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with IVC filters. Many of these complications occurred with long-term (greater than 30 days) filter implantation.
Health Canada has recently completed a review of the clinical evidence for the safety and effectiveness of IVC filters. Although there have been numerous clinical studies of IVC filters, there are only two randomized controlled trials (RCTs) of IVC filter use. In both studies, patients with documented Venous Thrombo-Embolism (VTE) were randomized to therapeutic anticoagulation alone or to therapeutic anticoagulation plus an IVC filter. Results from these two RCTs do not support the use of IVC filters in patients who can be treated with anticoagulation. Reductions in VTE and mortality have not been demonstrated.
Health Canada is communicating to healthcare professionals that IVC filters are appropriate for patients with certain types of blood clots, who cannot be treated with anticoagulant drugs. Health Canada is also working with the manufacturers of IVC filters to continue to monitor the post-market safety and effectiveness of IVC filters in Canada as well as worldwide.
For details, please visit the following Health Canada website:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/59518a-eng.php
Posted on 26 July 2016