Stroke Management

The emergency management of stroke is extremely time sensitive and the medical community knows the importance of acting quickly when assessing a stroke. Failure to properly diagnose and treat these cases can result in devastating long term injuries or death. There is an important therapeutic window to assess when diagnosed with a stroke. Once diagnosed, tPA, a potent clot busting drug, must be administered within 4.5 hours from the onset of stroke. If a mechanical thrombectomy is necessary, mechanical removal of a clot in a large vessel artery, must be conducted within 24 hours of onset of a stroke.

Analyzing the mismanagement of an ischemic stroke case involves understanding how to diagnose and treat, as well as an understanding of which interventions are necessary and when they should be used understanding that there is always. Risk of hemorrhagic (bleeding) complications.

Every patient who has suffered an ischemic stroke may have had unnecessary delays in treatment that resulted in avoidable disability. The Vigna Law Group will analyze each prospective client’s care from initial assessment, diagnostic test provided, and medical interventions provided.

Each case involving a thrombectomy is evaluated for hemorrhagic complications and ischemic injury relate to the defective Penumbra Jet 7.

The Vigna Law Group is evaluating thrombectomy cases and complications caused by the Penumbra Jet 7.

Greg Vigna, MD, JD, is Board Certified in Physical Medicine and Rehabilitation, as well as a stroke expert and national neurological injury attorney.

How a stroke is caused?

A stroke can be caused by a clot obstructing the blood flow to the brain or by a blood vessel rupturing and blocking blood flow to the brain. An ischemic stroke is a type of stroke which blocks blood flow to the brain. This accounts for over 80% of strokes. tPA (clot busting drug) is indicated for ischemic strokes less than 4.5 hours from onset and thrombectomies are indicated for large vessel stenosis or occlusion within 24 hours from onset. Bleeding complications following thrombectomy and tPA is a risk.

A hemorrhagic stroke is the result of an artery in the brain either leaking or rupturing, which causes pressure and damages brain cells. A transient ischemic attack (TIA), occurs from a minimal blockage of blood flow that typically lasts 5 minutes or less but are important because diagnostic testing may reveal significant narrowing of a large vessel such as the carotid or middle cerebral artery so interventions including thrombectomy, angioplasty, or carotid endartecectomy may prevent subsequent catastrophic stroke.

How can a blood clot be removed?

A hemorrhagic stroke is the result of an artery in the brain either leaking or rupturing, which causes pressure and damages brain cells. A mini stroke, also known as a transient ischemic stroke, occurs from a minimal blockage of blood flow that typically lasts 5 minutes or less.

What are the signs and symptoms of a stroke?

When a stroke occurs, the immediate diagnosis and response is critical to lessen any damage to your brain. Signs of a stroke include:

Numbness or weakness in face, arm, or leg and may present on just one side of the body. Drooping of the face.
Trouble speaking, slurred speech, or confusion
Sudden, severe headache
Loss of coordination
Vision loss or trouble seeing in one or both eyes

Pursing a Legal Claim for a Stroke Treatment Injury

Penumbra is a medical company that creates devices which treat a multitude of medical conditions including ischemic stroke, which is a stroke that blocks blood flow to the brain. Its Jet 7 System specifically treats ischemic stroke. On December 15, 2020 Penumbra issued an urgent, voluntary recall of its Jet 7 device. In its recall, Penumbra states, “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.”

The Jet 7 Xtra Flex was designed in response to the increased competition entering the market. The Jet 7 Xtra Flex was approved through the FDA’s 510(k) process. This process is less intensive than other processes the FDA administers to bring a product to market when the product demonstrates that is substantially equivalent to its predecessor and is safe and effective. Despite its predecessor, in our research, we have identified that Penumbra’s Xtra Flex has a consistent breakage in its catheter, suggesting a flaw in the design of this product. The FDA has received over 200 Medical Device Reports from malfunctions of the Jet t Xtra Flex, resulting in injury and death.

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Stroke Management - Penumbra Jet 7 Lawsuit