An implant meant to block the flow of blood to a brain aneurysm has been recalled after the device's delivery mechanism was found to occasionally experience fractures, leaving dangerous pieces of wire or tubing inside the bloodstream.
Medtronic, which inherited the Pipeline Flex embolization device in its nearly $43 billion acquisition of Covidien in early 2015, initiated the recall in July. This week, the FDA categorized it as Class I, the agency’s most severe, linking the device in question to an increased risk of serious injury or death.
The Pipeline Flex device is a cylindrical, wire-mesh stent composed of platinum, tungsten and cobalt-chromium-nickel alloy. It’s placed across the base of an aneurysm from inside the carotid arteries, to help lessen the pressure and return the blood vessel to its original shape.
The devices are also available with Medtronic’s Shield Technology, a synthetic coating for the stent that not only helps it slide more easily through the arteries but also stifles the body’s usual response to the placement of a metal object inside a blood vessel. That technology received FDA clearance only recently, in April of this year, but has been available outside the U.S. since at least 2019.
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device (Medtronic)
The stents are placed, adjusted and removed using a guidewire-based delivery system that’s at the root of the recall. Not only can fractured pieces cause blockages, strokes or death, but attempts to remove them may also worsen a patient’s condition.
So far two deaths have been linked to the recall, in addition to 10 serious injuries and another 59 reports of device malfunctions, according to the FDA.
The recall affects more than 8,800 devices distributed in the U.S. between April 2019 and August 2020, and more than 7,300 distributed internationally. Healthcare providers using any of the affected Pipeline Flex devices with or without Shield Technology are asked to immediately halt their use and return them to Medtronic.
The safety alert builds on a previous recall of the Pipeline Flex devices in March 2020, initially covering just over 800 units in the U.S., distributed between November 2019 and February 2020. At the time, one death had been linked to the delivery system’s breakages, plus 10 other injuries.
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The expanded Pipeline Flex recall is the latest in a spate of Class I safety issues for Medtronic’s products this year. At the beginning of the year, the medtech giant asked physicians around the world to stop using its Valiant Navion thoracic stent graft system, which fortifies weakened aortas using a synthetic fabric tube and metal stent scaffold, because of at least two instances in which the stent fractured, tearing the fabric tube and cause blood to leak out of the device’s channel.
More recently, in July, the FDA slapped a Class I rating on Medtronic’s call for returns or exchanges of nearly 55,000 guidewires distributed over a more than decade-long period between 2007 and 2021. The affected models were found to have not been sterilized before being shipped to hospitals, which could potentially lead to sepsis, other infections or death.
Perhaps the most serious of all Medtronic’s safety issues this year came in June, when the Dublin-based devicemaker opted to discontinue its HeartWare implantable heart pump, following three separate Class I recalls just this year that linked the device to more than a dozen deaths.