Onyx Liquid Embolic System by ev3: Risk of Catheter Entrapment

The FDA notifies Neurology and Surgery physicians and patients that risk of catheter entrapment of the Onyx Liquid Embolic System exists that can lead to serious complications, including hemorrhage and death.

Background of Onyx Liquid Embolic System

Onyx Liquid Embolic System, by ev3, is a copolymer used for embolization therapy which involves the occlusion of blood vessels. It is a liquid embolic agent used to block blood flow in abnormally formed blood vessels in the brain, brain AVMs, before their surgical removal. A catheter is used to deliver the Onyx liquid to blood vessels in the brain.

FDA Alert on Onyx Liquid Embolic System

If the catheter becomes stuck in the implanted Onyx material (catheter entrapment) serious complications might occur including migration of the Onyx plug or catheter fragment to other parts of the body, hemorrhage and death.

The risks are reflected to the changes to the physician and patient labeling approved by the FDA, including recommendations on how to minimize the entrapment risk.

FDA Recommendation on Onyx Liquid Embolic System

“Catheter entrapment is unlikely to affect the physician’s ability to surgically remove the patient’s AVM. However, neither Onyx nor the catheter is intended to be long-term implants, and patients may need additional medical interventions to have the catheter removed if it becomes entrapped.

• Neuro interventionalists should select patients carefully, after reviewing the most recent device labeling and instructions.
• Onyx is only approved for use in patients who will undergo surgical removal of the treated brain AVM.
• Onyx has not been tested or approved as a long-term implant.
• Healthcare professionals should be prepared to treat serious complications associated with the use of Onyx and ensure that your facility is staffed and equipped to address these complications should they arise.

Read the FDA Safety Communication for additional information.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Onyx Liquid Embolic System, including a difficult to remove or entrapped (retained) catheter while using Onyx, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.”

Contacting the FDA to report cases with Onyx Liquid Embolic System

In case of detection of adverse events or side effects related to the use of Onyx Liquid Embolic System, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

Please include the following information in your reports, if available:

• Adverse event details (date adverse event occurred; complications that occurred, e.g. retained or plugged catheter, migration of Onyx plug, hemorrhage of the brain AVM; and the medical intervention required)
• Type of Onyx used (e.g. Onyx 18 or Onyx 34)
• Expiration dates of Onyx, delivery catheter and all accessories used
• Model and size of catheter used with Onyx
• Location in the anatomy where Onyx was used
• Amount (distance) of reflux
• Whether vessel was in vasospasm
• Whether surgical resection is planned
• Location in the pedicle being embolized where the catheter got stuck. For example, proximity to the origin of the pedicle vessel and proximity to the Onyx plug.
• Whether additional medical therapies (e.g. antithrombotics) were needed

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