Penumbra Jet 7 Xtra Flex Catheter
Doctors use Penumbra Jet 7 Xtra Flex Catheters to remove blood clots and restore blood flow in stroke patients. Penumbra recalled thousands of catheters in December 2020 because they could fail or break, causing serious injury or death.
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The U.S. Food and Drug Administration cleared the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (Jet 7 Xtra Flex) for sale by 510(k) premarket notification in June 2019. FDA cleared the JET 7MAX configuration, which includes the JET 7 Xtra Flex catheter and MAX Delivery Device, for sale in February 2020.
The Penumbra Jet 7 Xtra Flex Catheter and JET 7MAX configuration are part of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. Doctors use these devices to perform a direct aspiration mechanical thrombectomy — a procedure that removes blood clots from blood vessels in stroke patients by vacuuming out the clot.
The Jet 7 Extra Flex Catheter is specifically for use in patients who suffer an acute ischemic stroke who are not eligible for or did not respond to clot busting drugs called t-PAs.
Clinical trials have shown that mechanical thrombectomy works better than treatment with clot busting drugs for stroke patients who suffer large vessel clots, according to a 2020 meta-analysis published by Pavlos Texakalidis and colleagues in Neurosurgery.
How Does the Jet 7 Catheter Work?
The Jet 7 Xtra Flex Catheter is a large diameter, single use, flexible catheter with a guide wire. It attaches to plastic tubing and an aspiration pump. The pump acts like a vacuum. The Xtra Flex technology was designed as an advancement to its Penumbra Jet 7 Reperfusion Catheter with Standard Tip.
Doctors insert the catheter through an artery in the groin, up through the neck and to the location of the blood clot causing the stroke. They use fluoroscopy, or continuous x-ray, to monitor the progress of the catheter as it travels through the artery.
Once the catheter reaches the blood clot, it sucks out the clot. This unblocks the blood vessel and restores blood flow. Doctors then guide the catheter back out of the body.
Side Effects and Complications
Side effects and complications linked to the Jet 7 Xtra Flex Catheter include device-related problems and side effects from fluoroscopy. These range from allergic reactions to increased risk of cancer from X-ray exposure, according to the risk information provided by Penumbra.
The risk information doesn’t specify how common side effects are. Patients should discuss risks with their medical provider.
- Allergic reaction and anaphylaxis from contrast media
- Acute occlusion (blockage)
- Air embolism (blockage in artery)
- Arteriovenous fistula (abnormal connection between artery and vein)
- Death
- Device malfunction
- Distal embolization (blockage in a coronary artery because of clot, broken guidewire or air)
- Emboli (blood clot, air bubble, fatty deposit or other object that can lodge in a blood vessel)
- False aneurysm formation (leaking blood in tissues surrounding an injured blood vessel)
- Bruising or hemorrhage at access site
- Inability to completely remove blood clot
- Infection
- Intracranial hemorrhage
- Ischemia (inadequate blood supply to a part of the body or organ)
- Kidney damage from contrast media used in fluoroscopy
- Neurological deficits including stroke
- Vessel spasm
- Thrombosis (blood clot)
- Dissection or perforation of blood vessels
- Radiation exposure that may lead to cataracts, skin reddening, burns or alopecia
- Cancer from x-ray exposure
Recall and Lawsuits
Penumbra recalled more than 30,000 Jet 7 Xtra Flex devices on Dec. 15, 2020. This recall doesn’t affect Penumbra Jet 7 Reperfusion Catheter with Standard Tip.
“Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death,” according to the company’s Urgent Voluntary Medical Device Recall Notification.
At the time of the recall, Penumbra said it was aware of 17 patient injuries and 14 deaths attributed to catheter tip damage, and expansion and rupture following contrast injection. A 2022 report in the Journal of the American Association noted there were over 200 adverse event reports concerning the Jet 7 Xtra Flex.
Shortly after the U.S. Food and Drug Administration announced the recall, lawyers began investigating Jet 7 Xtra Flex Catheter lawsuits on behalf of stroke victims injured by the device.
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