Health Canada Publishes Alert On IVC Filters

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Canada’s federal government recently issued an inferior vena cava filter (IVC filter) safety alert warning patients and physicians about associated complications. After receiving 121 reports of serious complications, Health Canada’s IVC filter safety alert has encouraged physicians to remove the devices within 30 days of implantation.

IVC filters have become a global safety concern following hundreds of reported injuries. Health Canada, the agency charged with safeguarding the nation’s public health, is equivalent to the United States Food and Drug Administration (FDA).

While the FDA initially released an IVC filter safety alert in 2010, the agency has issued multiple safety communications about the failed medical devices.

IVC filters are metallic, spider-like devices implanted in the inferior vena cava vein to catch blood clots and prevent migration to the lung. Some filters are considered permanent, whereas others are intended to be retrievable.

The medical device can cause life-threatening complications, including device migration/fracture, vein/organ perforation, and cardiac endangerment. IVC filters may also increase the risk of pulmonary embolism, a condition the device is intended to mitigate.

As described by Health Canada, complications linked to IVC filters include:

  • Vein perforation
  • Vein thrombosis
  • Filter fracture
  • Fragment embolization
  • Intracardiac migration
  • Cardiac perforation
  • Cardiac tamponade
  • Death

On July 25, 2016, Heath Canada contacted medical professionals to provide information about generalized IVC product dangers. After a clinical review, Health Canada has released recommendations encouraging physicians to take action.

“Although there have been numerous clinical studies of IVC filters, there are only two randomized controlled trials (RCTs) of IVC filter use,” according to the alert. “Results from these two RCTs do not support the use of IVC filters in patients who can be treated with anticoagulation.”

Health Canada has informed hospitals to identify patients with retrievable IVC filters. Medical professionals are encouraged to develop strategies for removing IVC filters, especially after the risk of PE has subsided. The alert specifically involves patients who received an IVC filter implant between 2003 and 2016.

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

In addition to contacting hospitals and implantation facilities, the agency is reaching out to at-risk patients with official warning letters to ensure an understanding of follow-up procedures.

Health Canada has taken precautions to help citizens affected by the flawed medical devices, which have been implanted in more than 250,000 people, stating, “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.”

Patients injured by failed IVC filters can learn more about available resources by connecting with an advocate.

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