Recalled Penumbra JET 7 Xtra Flex Catheter Causing Brain Bleeds
The JET 7 Xtra Flex is a popular catheter manufactured by Penumbra and is used to remove blood clots from the brain during thrombectomy procedures. However, reports have shown that the distal tip of the JET 7 Xtra Flex catheter can expand and fracture during the procedure which can result in injuries such as brain bleeds, hemorrhagic strokes, and even death. On December 15, 2020, Penumbra recalled all configurations of the Jet 7 Xtra Flex catheter after the FDA received over 200 reports detailing serious malfunctions and injuries involving the catheter.
Since the Penumbra JET 7 Xtra Flex catheter was introduced to the United States market in July 2019, there have been 12 reported deaths relating to surgeries where the device was used, according to the FDA’s MAUDE database.
What is Penumbra JET 7 Xtra Flex Catheter?
The JET 7 Xtra Flex is a widely used aspiration catheter that is manufactured by Alameda, California neurovascular device company Penumbra. Aspiration catheters are designed for use in thrombectomy procedures—specifically suction thrombectomy surgeries. The catheter is a thin tube that can be inserted into a person through an opening in the groin or wrist. The surgeon then guides the catheter to an arterial blood clot in the patient’s brain and uses the suction to remove the clot, resulting in the resolution of blood flow. Such blood clot removal is imperative when trying to prevent or treat ischemic strokes.
Penumbra has designed several generations of aspiration catheters since first receiving FDA approval in 2007. Their products became so popular that from 2007 to 2018, 80% of all suction thrombectomies performed in the United States used Penumbra aspiration catheters. Even today, Penumbra’s aspiration catheters are used in nearly 65% of the 45,000 to 50,000 suction thrombectomies that occur each year in the United States.
What Type of Surgery Uses the JET 7 Xtra Flex Catheter?
JET 7 Xtra Flex catheters are most commonly used in thrombectomy surgeries. A thrombectomy is a surgical procedure that removes blood clots from arteries and veins. The surgery occurs by creating an incision in the blood vessel, removing the clot, repairing the blood vessel, and restoring blood flow. If blood clots go untreated, they disrupt the normal flow of blood through the body and can cause potentially fatal conditions such as a pulmonary embolism or an acute stroke.
What Can Go Wrong?
Surgeons have alleged that while they are attempting to remove blood clots from their patients’ brains, the Penumbra JET 7 Xtra Flex catheter’s distal tip would suddenly expand or fracture. Product failure due to distal tip expansion results in the catheter expanding like a balloon inside of an artery in the patient’s brain. That expansion can be several times the diameter of the patient’s artery which can rupture the blood vessel, cause massive hemorrhaging (bleeding) in the brain, and result in death. Product failure due to distal tip fracture can result in detachment of the broken portion of the catheter inside the artery within the patient’s brain. This can also cause serious injuries requiring complex interventions to find and remove the distal tip.
What are the Reports Saying?
The U.S. Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database listed 12 entries detailing deaths after 2019 and 2020 operations that involved the JET 7 Xtra Flex catheter. In these tragedies, expansion or fracture of the device’s distal tip caused the complications. Eight reports noted at least one arterial rupture—many of which occurred in the internal carotid artery which provides blood to the brain and eyes.
What Has Penumbra Said?
Penumbra informed healthcare providers in July 2020 that it had received reports of the Penumbra JET 7 Reperfusion catheter with Xtra Flex Technology (JET 7 Xtra Flex) resulting in distal tip expansion or rupture when used during the injection of a contrast media. The company acknowledged that the JET 7 Xtra Flex can expand or rupture during contrast injection due to distal tip weakening and that distal tip expansion or rupture can cause vessel damage, patient injury, and even death.
GoldenbergLaw Can Help
Contact GoldenbergLaw’s experienced Stroke and Brain Bleed Attorneys for a free Penumbra Jet 7 Xtra Flex lawsuit consultation to get the Gold standard advocacy that you deserve. GoldenbergLaw’s attorneys have over thirty years of experience litigating on behalf of thousands of people who have suffered injuries due to defective medical devices. Contact us today, and leave the sleepless nights to us.