3.2.20
By Mike Smith
Last month, Medtronic began a Class 1 recall of 822 units of its Pipeline Flex Embolization Device due to risk of device fracture, which can lead to serious patient injury or death, according to the FDA Recall Notification.
According to the FDA, the product (“Pipeline Flex”) is a permanent mesh cylinder (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). The Pipeline Flex also includes a guidewire-based delivery system used to place the implant inside the patient.
The mesh stent does not seem to be the problem, but rather the delivery system that carries the stent to the aneurysm and implants it within the arterial wall, according to the FDA:
Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside the patient.
Fractured pieces of the delivery system could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the patient’s condition worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.
If a Pipeline Flex Embolization Device (the permanent flow diverting stent) has already been implanted successfully, there is no increased risk to patients due to this issue.
The FDA received 50 Medical Device Reports, with 10 injuries and 1 death, from November 1, 2019 to March 1, 2020.