The FDA issued a warning on Friday (June 29, 2012) regarding an implantable medical device manufactured by Covidien Plc subsidiary ev3’s Onyx Liquid Embolic System, which the Agency said has been associated with at least nine patients deaths and dozens of adverse events.
The device is used to block the flow of blood in affected blood vessels in patients with brain arteriovenous malformations (AVMs) before the vessels are surgically removed. In its warning the FDA explained adverse event reports indicate numerous occurrences in which the device could not be removed and had to be left in the patient.
The FDA said the devices are not intended for long-term implantation. It noted serious risks associated with “catheter entrapment,” including hemorrhage and death. The Agency also cautioned that catheters could break, causing fragments to migrate to “other parts of the body.”
RAPS Regulatory Focused explained that ev3’s premarketing data submission to FDA had highlighted similar issues. Noting that all devices in the clinical trial had been successfully removed from patients despite being “difficult to remove.”
The FDA ordered changes to the product’s patient and physician labeling in April 2012, and is now recommending further precautions based on the risks associated with Onyx.
The Agency impressed the imperative need for physicians to follow the manufacturers’ specific instructions on how to remove an entrapped catheter. It’s warning made it clear to physicians “[a]ggressive attempts to remove the catheter can result in catheter breakage or brain hemorrhage…”
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