Jet 7 Xtra Flex stroke catheter complications can be serious or life threatening, either worsening ischemic stroke symptoms or causing other issues.

Penumbra Jet 7 Flex Catheter: Overview

The Jet 7 Xtra Flex catheter was a revascularization device used to treat ischemic strokes. An ischemic stroke is one of three primary stroke types and is the most common. According to Healthline, 87% of all strokes are ischemic strokes.

Unlike other types of strokes, which are caused by brain bleeds or short term blockages, an ischemic stroke is caused by a significant blockage in the blood vessels of the brain. These blockages can be dissolved by a medication or can be manually removed with a device such as the Jet 7 Xtra Flex catheter.

The Penumbra catheter was designed to be guided to the location of a blood clot where the blockage can be suctioned and removed – restoring blood flow or “revascularizing” the brain.

Jet 7 Xtra Flex Stroke Catheter Complications

The Penumbra catheter has been associated with over 200 medical device reports detailing malfunctions which caused serious injuries and even deaths. These reports include 14 unique patient deaths which have been linked to issues with the device.

According to these reports, the end of the Penumbra Jet 7 Xtra Flex stroke catheter can balloon, expand, rupture, break, sperate, or expose internal support coils. This can reportedly lead to complications such as vessel damage, hemorrhage, or continued cerebral infarction (lack of blood to the brain).

When the catheter experiences breakage while in a blood vessel, it can cause damage to the blood vessel. Although catheters are designed to fit within a blood vessel, a damaged catheter can expand beyond these bounds – leading to rips or tears in the blood vessel.

In turn, this can lead to hemorrhage or bleeding in the brain. This localized bleeding can cause another type of stroke – a hemorrhagic stroke – and lead to brain damage. Bleeding from a blood vessel trauma causes localized swelling in the brain – increasing pressure on other parts of the brain and restricting blood flow to these areas. As a result of the bleeding, swelling, and lack of oxygen, brain cells can be damaged or destroyed, according to WebMD.

Even in situations where Jet 7 Xtra Flex stroke catheter complications are not inherently deadly, these issues may make it difficult or impossible to accomplish the catheter’s main goal of revascularization. As a result, an ischemic stroke and lack of oxygen to the blood could continue – eventually leading to irreversible brain damage or death.

Due to reports of these potential complications filed with the FDA’s adverse event database, Penumbra recalled the catheter in December 2020. According to the FDA’s recall announcement, bench testing done by Penumbra showed that the catheter’s distal tip was unable to withstand the same burst pressure as other revascularization catheters from the manufacturer.

“Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use,” the manufacturer revealed in their own recall announcement. “Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death.”

The FDA has directed healthcare professionals to stop using the catheters, return the recalled products to Penumbra, and report any related adverse events they may have experienced.

Although the catheter is now off the market, patients may have still suffered from these issues while the device was being sold and used around the country.

How Do I Know If I’ve Experienced Penumbra Catheter Complications?

Unfortunately, many of the complications reported with the Jet 7 Xtra Flex catheter may occur during surgery – meaning that patients do not know that they have suffered from complications. Instead of patients realizing that they have suffered a life threatening complication, it may be their loved one who is given the news that the patient has died as a result of these issues.

However, if patients managed to survive Penumbra complications, they may still be struggling with the long term consequences of this experience. If their stroke symptoms were allowed to continue longer than intended, they may suffer from disabilities and decreased quality of life. Other complications may lead to brain damage – causing long term consequences and deficiencies for patients even long after they recover from a stroke.

Patients who were affected by Penumbra catheter complications or the loved ones of these patients may be eligible to seek compensation through legal action. A qualified legal professional can review your situation to determine your eligibility.