Dive Brief:

• FDA has classified another recall of Medtronic's Pipeline Flex embolization device for treating brain aneurysms as a Class I event after receiving reports of 59 malfunctions, 10 serious injuries and two deaths, the agency said Monday.
• Medtronic is recalling 8,825 devices in the U.S. due to a risk that the delivery system's wire and tubes could fracture when the stent is implanted or retrieved, leaving pieces in the patient's brain bloodstream, FDA said.
• The expanded recall of the Pipeline Flex device comes five months after Medtronic announced FDA approval of an updated version of the treatment incorporating the new shield technology, a modification in the surface material of the implant.

Dive Insight:

Medtronic first introduced the Pipeline device a decade ago as a way to address intracranial aneurysms by diverting blood flow. The device has been widely adopted as a treatment to prevent rupturing of the aneurysm, which kills an estimated 500,000 people each year, according to the company.

Using a guidewire-based delivery system, a braided mesh tube made from platinum and tungsten and cobalt-chromium-nickel alloy wires is implanted across the base of the aneurysm to reconstruct the diseased section of the blood vessel.

FDA initially flagged a fracture risk with the Pipeline Flex device in March 2020. At the time, just 822 of the products were recalled.

The latest recall covers multiple models of both the Pipeline Flex Embolization Device and the Pipeline Flex Embolization Device with Shield Technology, according to FDA. Medtronic initiated the recall on July 13 and the affected devices were distributed between April 18, 2019, and August 13, 2020.

Including products outside the U.S., which include the newer versions, the numbers recalled top 16,000, according to the FDA notice. 

The company published one-year results from a single-arm post marketing so-called SHIELD study demonstrating 77.2% occlusion, or closure of the diseased portion of the blood vessel. Of 204 people with the device implanted, about 8% were deemed to have device-related serious adverse events, that study found. 

CEO Geoff Martha told investors in August that although the neurovascular business lost share over the prior year, he was "pleased with momentum" with product launches in the space, including Pipeline Flex's new shield technology.

In its letter to healthcare providers, Medtronic said it has received reports of 71 confirmed and unconfirmed fractures, including reports of 10 serious injuries and two deaths, in connection with use of the delivery system. During a fracture, the distal section of the pushwire separates from the device delivery system and may cause significant patient injury, the company said.

An investigation determined the root cause, and corrective actions have been taken to address the issue, the letter added.

Medtronic advised healthcare providers to remove any devices affected by the recall from inventory and to return the products to the company.

This story has been updated to add detail on products outside the U.S.