- FDA on Monday alerted patients and healthcare providers to Medtronic's recall of its Pipeline Flex stent and guidewire-based delivery system used to treat brain aneurysms because the device has the potential to fracture during the implantation procedure.
- Regarding the Class I recall, FDA said it received 50 reports of the issue, including 10 injuries and one death, between Nov. 1, 2019, and March 1.
- The Pipeline Flex device, originally approved to treat large or giant wide-necked intracranial aneurysms, received an expanded indication from FDA in February 2019 to treat certain small or medium aneurysms.
The issue prompting the recall of Medtronic's treatment lies with the delivery system used to place the stent in the patient. If it fractures, pieces of the delivery system could be left in the bloodstream, potentially leading to a blockage of the vessel, stroke or death.
FDA said attempts to retrieve fractured pieces of the delivery system could worsen a patient's condition, but if the stent is already successfully implanted, there is no increased risk to the patient.
"Remove and quarantine all unused affected products in your inventory" and return them to Medtronic, the agency said in Monday's alert.
The Brain Aneurysm Foundation estimates that 6.5 million people in the U.S. have an unruptured brain aneurysm, with about 30,000 experiencing a rupture each year. Of those who suffer a brain aneurysm rupture, about half will die. Stryker, Johnson & Johnson and Terumo are among the companies making treatments for the condition.
Medtronic's metal mesh Pipeline Flex stent is implanted in the artery to divert blood from entering the aneurysm, an abnormal, bulging sac that can develop in the weakened wall of the vessel that supplies blood to the brain. The aim is to prevent the aneurysm from rupturing the vessel.
The device giant gained its expanded approval for the Pipeline Flex device based on clinical data from the Premier clinical trial of 141 patients, which showed a 76.7% rate of occlusion, or closing of the aneurysm, at one year.
The product is part of Medtronic's Restorative Therapies Group, which grew 4.2% to $2.11 billion in revenue in the company's fiscal third quarter. Within the group, brain therapies revenue rose 8.6% to $795 million, with its neurovascular division posting mid-teens constant currency growth.
Healthcare providers are urged not to use any affected Pipeline Flex products and to return them to Medtronic. The devices were manufactured from Oct. 22, 2019 to Feb. 1, 2020 and distributed from Nov. 6, 2019 to Feb. 7, 2020. In the U.S., 822 of the devices are being recalled.