(Reuters) -The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic’s embolization device as “most serious”, following reports of the deaths of four patients.
The use of the affected product could lead to severe adverse health consequences, including thrombosis, stroke, or death, the agency said.
There have been thirteen reported injuries associated with the use of devices known as Pipeline Vantage Embolization devices.
The recall impacts the Pipeline Vantage devices compatible only with 0.027″ inner diameter microcatheters, Medtronic said. The company added that it has taken the necessary steps to retrieve the recalled products and has notified regulatory agencies globally as appropriate.
The devices in question are used to treat bulges in the artery walls, or aneurysms, of the brain.
They are inserted into the blood vessels via a small catheter and delivered to the aneurysm site, where a small, braided tube is placed to obstruct blood flow to the bulging area.
The recall involves the withdrawal of the device models from all locations where they are currently in use or for sale.
Medtronic is recalling the devices following reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures involving these devices.
Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices, the regulator said, adding that the risks were higher in females, especially those younger than 45 years of age.
(Reporting by Sriparna Roy in Bengaluru; Editing by Mohammed Safi Shamsi)
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