Within four months, the Food and Drug Administration (FDA) received 50 medical device reports, involving 10 injuries and 1 death among patients treated with a Medtronic device used to repair brain aneurysms. The reports were received from Nov. 1, 2019 to March 1, 2020.
As a result, Medtronic is recalling 822 of its Pipeline Flex Embolization Devices and Pipeline Flex Embolization Devices with Shield Technology. The permanent mesh cylinders, which include a guidewire-based delivery system, are used to treat brain aneurysms that bulge or balloon out of the sides of the blood vessel. The devices were distributed in the United States from Nov. 6, 2019 to Feb. 7, 2020.
The FDA has identified this recall as a Class I, meaning it is the most serious type of recall and use of these devices may cause serious injuries or death.
Medtronic issued the recall after discovering that the delivery system could fracture while placing the stent inside the patient. The fractured pieces could be left inside the patient’s brain. This, or attempts made to retrieve the fractured pieces, can worsen the patient’s condition as well as cause other serious adverse medical issues such as continued blockage of blood vessels, stroke, and death. Patients who have successfully been implanted with a Pipeline Flex Embolization Device are at no increased risk due to this issue.
Anyone who has personally experienced an issue with the Medtronic Pipeline Flex Embolization Device, or has had a loved one who suffered injuries following aneurysm repair involving a Pipeline Flex Embolization Device, should file a report with the FDA MedWatch Adverse Event Reporting Program.