Medtronic has issued an urgent field safety notice to warn on specific production lots of its Pipeline Flex embolisation devices due to the potential for device fracture.
The company initiated verbal communication about the issue last month after identifying the potential for device fracture at the distal section during use, 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, which could cause significant patient injury, including a prolonged procedure, ischaemic stroke, intracranial haemorrhage, neurological deficit and/or death.
Medtronic has not received complaints related to the issue within the affected population, but the company is recalling the affected products due to the increased potential for fracture, according to the field safety notice.
If a Pipeline Flex embolization device was already successfully implanted, there is no increased risk to patients due to the issue, and those patients can continue with their normal course of treatment. The affected lots include devices with a “use-before” date on or after 21 October 2022.
The company urged those affected by the issue to cease the use of any affected products and to remove and quarantine all unused devices in their inventory before returning them to Medtronic.
Pipeline Flex is designed for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments. In February 2019, it won expanded US Food and Drug Administration (FDA) indication for patients with small or medium wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.