Inferior Vena Cava (IVC) Filters - Risk of Serious Complications

Starting date:
July 25, 2016
Posting date:
July 25, 2016
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
Healthcare Professionals
Identification number:
RA-59518

Audience

Physicians who request or implant Inferior Vena Cava (IVC) filters and clinicians responsible for follow-up care; radiologists, cardiologists, vascular surgeons, thrombosis specialists, internists, emergency physicians, bariatric surgeons, orthopaedic surgeons, primary care physicians

Please distribute to relevant Departments and appropriate personnel who use these filters.

Key Messages

  • Serious complications have been reported in patients implanted with an IVC filter, including caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death. Many of these complications occurred with long-term (greater than 30 days) filter implantation.
  • Healthcare professionals should carefully consider the indications for IVC filters. Health Canada considers the following indications appropriate given available clinical data:
    • Patients with acute proximal deep vein thrombosis (DVT) of the leg and a contraindication to anticoagulation
    • Patients with acute pulmonary embolism (PE) and a contraindication to anticoagulation
  • Retrievable IVC filters are intended for short-term placement and, when possible, should be removed when anticoagulation therapy can be started or if a patient's risk of PE subsides.
  • Health Canada encourages each hospital to identify all patients who have a retrievable IVC filter placed and to develop a formal strategy to assess these patients for filter removal.
 

Issue

As of June 6, 2016, Health Canada has received 121 incident reports of serious complications associated with IVC filters. 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. These complications have also been reported internationally.

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

Background information

In general, the approved IVC filters licensed for use in Canada are indicated for the prevention of pulmonary embolism (PE). IVC filters can be categorized as permanent IVC filters or retrievable IVC filters (also known as "optional").

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.Footnote 1,Footnote 2,Footnote 3 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.

Who is affected

Advice for consumers

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.

Retrievable filters are intended for temporary use only. If you have a retrievable IVC filter, talk to your healthcare professional about when the time is right to have it removed. Permanent filters are not intended to be removed.

Talk to your healthcare professional if you are unsure what type of IVC filter you have, or if you have any questions or concerns about your IVC filter.

Information for healthcare professionals

Although clinical decisions must be made on a case-by-case basis, Health Canada considers that the following indications for use, which are consistent with the recommendations made by American College of Chest Physicians guidelines (10th edition) state on the use of IVC filters for the prevention of pulmonary embolism,Footnote 4 are appropriate given the available clinical evidence at this time:

  • Patients with acute proximal DVT of the leg and a contraindication to anticoagulation
  • Patients with acute pulmonary embolism (PE) and a contraindication to anticoagulation

Retrievable IVC filters are intended for short-term placement and should be removed when anticoagulation therapy can be started or if a patient's risk of PE subsides. Patients who receive a retrievable IVC filter should be scheduled for a retrieval assessment at the time of placement of an IVC filter. If the individual risk/benefit assessment indicates that a retrievable IVC filter should be removed, the patient should be referred for IVC filter removal when feasible.

Health Canada encourages physicians to participate in clinical studies or develop plans for long-term follow-up of the patients implanted with IVC filters so that data can be collected on the safety and effectiveness of IVC filters within specific patient populations in Canada. Manufacturers are now required by Health Canada to collect post-market data for the licensed IVC filters; therefore some studies may be started or on-going.

Action taken by Health Canada

Health Canada is 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. Health Canada has required manufacturers to put in place post-market evaluations, which could include Canadian registries, to further understand appropriate patient populations that should be treated with IVC filters. Health Canada is also communicating this important safety information to healthcare professionals via fax, publication on Healthy Canadians Web site and MedEffect™ e-Notice.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving IVC filters should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

References

  1. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. N Engl J Med 1998;338(7):409-15.
  2. The PREPIC Study Group, Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC. Circulation 2006;112(3):187-8.
  3. Mismetti P, Laporte S, Ennezat PV, et al.  Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism; a randomized clinical trial, JAMA 2015;313(16):1627-35.
  4. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest 2016;149(2):315-52.

For more information

Health Canada conducted a regulatory review of these products. A Summary Safety Review is not required.