The FDA has issued a Class I recall of the Medtronic Pipeline Flex embolization device and the Pipeline Flex embolization device with shield technology.
The company manufactured the affected products from Oct. 22, 2019, to Feb. 1, 2020, and distributed them between Nov. 6, 2019, and Feb. 7, 2020. In total, Medtronic has recalled 822 devices in the U.S.
Medtronic discovered the potential for fracture at the distal section of the instruments due to a weakened bond in a subset of recently manufactured devices. Use of the affected product could result in unintended separation, where the distal portion of the device delivery system remains in the patient. This could lead to significant patient injury, ischemic stroke, intracranial hemorrhage, neurological deficit, and/or death.
Users are urged to cease the use of any affected products and return them to Medtronic. If an alternative is needed, a Medtronic representative can assist with finding a suitable replacement
According to Medtronic, its Pipeline Flex embolization device is now indicated for patients with small or medium, wide-necked brain aneurysms. The device was previously cleared for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms, Medtronic said.
Clearance came based on data from the 141-patient PREMIER trial of the device, which reported a one-year occlusion rate of 76.7% with the use of 1.1 device per subject on average. The study also reported an average 2.2% rate of major stroke or neurological death, according to the company.
The Pipeline Flex device is designed to divert blood away from aneurysms. The tool features a braided cylindrical mesh tube which cuts off blood flow and reconstructs the diseased section of the parent vessel.
“Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission. The Premier study not only demonstrated excellent safety and efficacy outcomes but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment,” neurovascular biz GM Stacy Pugh said in a press release.