Pipeline Flex (embolization device)

2021

Withdrawal of defective devices

On September 20, 2021, the US Food and Drug Administration (FDA) published a notice confirming the recall of the Pipeline Flex embolization device from Medtronic. Regulators have classified the recall as Grade I, meaning the problem identified can lead to serious injury or death of the patient.

Several Pipeline Flex models and embolization devices with Shield Technology came under review. In the United States, 8.8 thousand devices are recalled, which were distributed between April 18, 2019 and August 13, 2020.

Medtronic recalls defective embolization devices that cause patients to die

According to a release from the U.S. Food and Drug Administration, Medtronic initiated a recall on July 13, 2021. In connection with the recall, 59 cases of device malfunction, 10 serious injuries and two deaths were recorded.

The company withdrew the devices due to the risk of broken and broken wire and tubes of the delivery system when the system is used to install, remove or move the stent inside the patient. Broken fragments may remain in the patient's brain bloodstream, and attempts to extract broken fragments may worsen the patient's condition. Fragments can also cause other serious negative health effects, including continued blockage of blood vessels, stroke, or death.

In line with our safety and transparency commitments, Medtronic has identified an opportunity to raise awareness of a potential patient safety issue by voluntarily sending a letter to our user physicians to notify them of the voluntary recall of the Pipeline Flex embolization device. The company received reports of a pressure wire fracture in the distal portion of the Pipeline delivery system during use. During the investigation, we found that the main reason for the fracture of this delivery cable belongs only to a subset of devices. To eliminate the main problem that caused the delivery wire fracture, corrective measures have already been taken, "commented David T. Young, representative of Medtronic.

In connection with the latest recall, Medtronic instructed customers to stop using all exposed products, and all unused exposed products should be quarantined immediately. Eventually, these products must be returned to Medtronic, and customers should contact a Medtronic representative for assistance in returning the products or to select a suitable replacement, if necessary.^[1]

Pipeline Flex Announcement with Shield Technology for Treating Cerebral Aneurysms

At the end of April 2021 Medtronic , she introduced the Pipeline Flex medical embolization system with Shield technology, which allows interrupting blood flow in the aneurysm of the cerebral vessels brain and preventing rupture of the aneurysm.

Pipeline Flex, introduced to the US market for almost 10 years, is a system for diverting blood from a cerebral aneurysm. The braided cylindrical mesh tube is implanted through the base or neck of the aneurysm, interrupts blood flow in the aneurysm and restores blood flow in the affected area of the maternal vessel.

Pipeline Flex device with Shield technology for treating cerebral aneurysms

Medtronic's Shield technology is a patented platform that allows you to improve this type of therapy. Due to the modified surface, the thrombogenicity of the material is reduced, that is, the tendency to form blood clots, which means that the frequency of complications when implanting the device is reduced. In addition to solving the problem of thrombogenicity of the material, Shield Technology improves the effectiveness of therapy by reducing the strength required for both delivery and reinstallation of the implant.

NYU Langone Health Hospital has successfully completed the first blood flow recovery procedure with a Pipeline Flex device with Shield technology. Data from the SHIELD study, published in the journal NeuroInterventional Surgery (JNIS) in June 2020, showed that a device with Shield technology is characterized by high safety and efficiency.

We believe that the Pipeline Flex device has changed the paradigm of treating brain aneurysms, and Shield Technology opens up new opportunities for doctors to further improve treatment outcomes, "said Dan Volz, president of Medtronic's department for the treatment of neurovascular diseases[2]

2020: Defective Batch

In early March 2020, Medtronic issued an urgent safety notice to warn of defective Pipeline Flex embolization devices capable of causing stroke.

Pipeline Flex is designed for the enduscular treatment of adult patients with large or giant intracranial aneurysms. In February 2019, its indications for use were expanded, and it can now be applied in patients with small to medium brain aneurysms.

Medtronic issues urgent safety notice to warn of defective Pipeline Flex embolization devices capable of causing stroke

In February 2020, Medtronic became aware that in several batches of devices a production scrap went unnoticed, which the manufacturer orally reported the problem to customers. The use of a defective product can lead to unintentional separation of the distal portion of the system that enters the patient's bloodstream. In turn, this can lead to serious injuries, including ischemic stroke, intracranial hemorrhage, neurological deficits, and/or death. Even in cases where the separated distal portion of the system does not cause injuries, a long operation to remove it awaits the patient.

Medtronic did not receive complaints related to this problem, but the company recalls defective products "due to the increased likelihood of cracks and separation of the distal department," as stated in the notice. If the Pipeline Flex embolization device has already been successfully implanted, there is no risk of injury and these patients can continue the normal course of treatment. The defective lots include devices with an expiration date of October 21, 2022.

The company urged customers to stop using defective products, and to collect and isolate all unused devices that may be present in the hospital to then return them to Medtronic.^[3]

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