What Does a Successful Thrombectomy Procedure Look Like?

What Is a Thrombectomy Procedure, and Why Is It Done?

A surgical thrombectomy is a procedure to remove a blood clot from inside an artery within the brain. 

Blood clots can form as a result of the blood thickening and clumping within one of the vessels. As a result of the blood clot, the blood flow can be restricted or blocked. Decreased blood flow can damage nearby brain tissues.

How Is a Thrombectomy Procedure Done?

In a surgical thrombectomy, an IV is first put into the patient’s arm or hand to allow for delivery of medications such as a blood thinners and anesthesia during the procedure. If a patient has hair in the area where the incision will be made, the hair will likely be removed. Continuous X-ray imaging is frequently used during the procedure to guide the surgeon to the precise location of the blood clot. The surgeon will then make an incision above the blood clot, open the blood vessel, and remove the blood clot. A stent may be put in the blood vessel to help keep it open so the clot can be removed. 

In catheter aspiration thrombectomies, the surgeon will make an incision in the groin and advance the catheter through the artery or vein to reach the blood clot within the blood vessel. The Penumbra JET 7 Xtra Flex catheter was one of the most widely used catheters in thrombectomy procedures prior to its recall in December 2020. The catheter’s distal tip is then placed next to the clot and negative pressure is applied at the distal tip of the catheter through suction. This is done in order to remove the blood clot through the catheter. Once the blood clot has been completely removed, the incision is closed and bandaged to conclude the surgery.

What Can Happen If a Thrombectomy Procedure Goes Wrong?

There are potentially fatal complications if a surgical thrombectomy goes wrong. The U.S. Food and Drug Administration (FDA) received hundreds of reports of adverse events stemming from the use of Penumbra JET 7 Xtra Flex catheters during thrombectomy procedures. The Jet 7 catheter was recalled due to reported distal tip malfunctions. When the Jet 7 catheter’s distal tip malfunctions, it can quickly expand to become multiple times the size of the blood vessel and create pressure on the vessel which can cause it to weaken. If the blood vessel becomes too weak it can rupture, resulting in substantial bleeding in the surrounding area of the brain. 

Excess blood in the area of the brain surrounding the ruptured blood vessel can overwhelm brain tissue, compress it, and cause significant damage. Additionally, other areas of the brain more distant from the ruptured blood vessel can also be damaged, as those areas receive reduced blood flow due to the large amount of excess blood concentrated in the specific area of the brain where the blood vessel ruptured.

A stroke can occur when the flow of blood to part of the brain is cut off or significantly reduced. Since the blood flow is reduced, the brain cells are deprived of the oxygen from the blood which causes them to die quickly. This can cause a patient’s death or permanent brain damage. The severity of a stroke depends on where the stroke occurs in the brain and how much brain tissue was damaged.  

After the FDA received more than 200 reports of adverse events from thrombectomy procedures where a Penumbra JET 7 Xtra Flex catheter was used, Penumbra Inc. issued a voluntary recall in December 2020 of all its Penumbra JET 7 Xtra Flex catheters. 

To learn more about the dangers of the Penumbra JET 7 Xtra Flex catheter failures, read the blogs from GoldenbergLaw’s Penumbra JET 7 Xtra Flex Cather Resource Center found below: 

Penumbra JET 7 Xtra Flex Catheter Resource Center

GoldenbergLaw Can Help

If you or a loved one was harmed by a thrombectomy procedure where a Penumbra JET 7 Xtra Flex catheter was used, contact the Brain Bleed Attorneys at GoldenbergLaw today. With thirty-four years of experience, the attorneys at GoldenbergLaw will advocate for you so that you can receive the justice you deserve. Contact us today for a free Penumbra catheter lawsuit consultation and leave the sleepless nights to us!

 

Why Was the Penumbra JET 7 Xtra Flex Catheter Recalled?

On December 15, 2020, the U.S. Food and Drug Administration (FDA) announced Penumbra, Inc.’s recall of all Penumbra JET 7 Xtra Flex catheters due to the “risk of unexpected death or serious injury.” Penumbra, Inc.’s recall included a warning that all medical facilities who used the Penumbra JET 7 Xtra Flex catheter should remove them from their inventory.

How the Penumbra JET 7 Xtra Flex Catheter Is Supposed to Work

The Penumbra JET 7 Xtra Flex catheter is part of the Penumbra System which was designed to work in tandem with the Penumbra Aspiration Pump, Penumbra Aspiration Tubing, and the MAX delivery device to restore blood flow by removing blood clots. This intended to be achieved by using continuous aspiration (a method that uses suction to remove a blood clot) in patients who have suffered from an acute ischemic stroke within 8 hours of symptoms appearing. The Penumbra JET 7 catheter series was intended to deliver deeper vacuum aspiration power to allow the practitioner to safely extract blood clots in acute ischemic stroke patients.

During a catheter-based thrombectomy procedure, the surgeon makes an incision in the groin and advances a catheter through an artery all the way to the blood clot. The surgeon uses an X-ray to guide the catheter to the blood clot. The catheter then removes the blood clot from the blood vessel in order to restore blood flow. 

Penumbra JET 7 Xtra Flex Catheter Resource Center

Penumbra JET 7 Xtra Flex Catheter Defects

The FDA has received more than 200 medical device reports associated with the Penumbra JET 7 Xtra Flex catheter. The reports include complications such as death, serious injuries, and malfunctions. The report listed device failure modes as “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.” 

The distal tip is located at the very top of the catheter and is what makes contact with the blockage within the vessel. However, in the case of the Penumbra JET 7 Xtra Flex catheter, the distal tip may expand to become several times the diameter of the blood vessel. This expansion can put undue pressure on the weakened blood vessel and can lead to an increased risk of rupturing. If the blood vessel ruptures within the brain, the brain tissue can be flooded with excess blood which causes damage to the brain and may result in a serious brain bleed (a hemorrhagic stroke) or even death. 

Penumbra, Inc. conducted testing that confirmed this potentially fatal complication. To come to this conclusion, the manufacturer compared the Penumbra JET 7 Xtra Flex catheter to its other aspiration catheters. It determined that the Penumbra JET 7 Xtra Flex catheter’s distal tip could not withstand as much pressure as the other aspiration catheters before failing–resulting in the distal tip expanding and potentially causing the blood vessel to rupture. This means that the Penumbra JET 7 Xtra Flex catheters have an increased risk of failure compared to other aspiration catheters. The FDA confirmed these concerning findings in its December 15, 2020 announcement of Penumbra, Inc.’s voluntary recall of the Penumbra JET 7 Xtra Flex catheter.

GoldenbergLaw Can Help

If you or a loved one have been harmed by a Penumbra JET 7 Xtra Flex catheter malfunctioning, contact the Hemorrhagic Stroke Attorneys at GoldenbergLaw who have more than thirty years of experience in fighting for justice. Contact us today for a free Penumbra Jet 7 lawsuit consultation and let us give you the Gold standard of advocacy you deserve!

Rehabilitative Care After Penumbra JET 7 Xtra Flex Catheter Injury

One of the most serious complications of a Penumbra JET 7 Xtra Flex catheter malfunction is a hemorrhagic stroke–commonly known as a brain bleed. A brain bleed occurs when blood begins bleeding into the brain, usually as the result of a weakened blood vessel rupturing. The bleeding creates pressure in the brain which can damage brain cells and result in diminished or complete loss of function in the impacted area of the brain. 

A hemorrhagic stroke is one of the injuries linked to the Penumbra Jet 7 Xtra Flex Catheter. The primary defect of the Penumbra Jet 7 is that the distal tip of the catheter can expand or balloon while inside a blood vessel. If the catheter balloons during a procedure it can become multiple times the size of the blood vessel and cause the blood vessel to burst. The bursting of the blood vessel may cause a hemorrhagic stroke to occur. 

Emergency Treatment of Hemorrhagic Strokes

The goal of emergency treatments for hemorrhagic strokes is to control the bleeding and reduce the pressure on the brain caused by the extra blood. Emergency treatments include

  • Drugs or transfusions to counteract effects of any blood-thinning medications a patient may be taking to prevent blood clots, reduce the pressure on the brain, lower blood pressure, prevent blood vessel spasms, and reduce the probability of seizures;
  • Surgical removal of the blood and reduction of pressure on the brain; 
  • Surgical clipping to place a clamp at the base of aneurysm to stop the blood flow; 
  • Endovascular embolization utilizing a catheter inserted into an artery in the patient’s groin, guided to the brain, and used to place tiny detachable coils into the aneurysm to block the blood flow and make the blood clot; 
  • Surgical AVM (arteriovenous malformation) removal to close an abnormal connection between blood vessels in order to prevent bleeding and rupture; and
  • Stereotactic radiosurgery using multiple beams of radiation to repair blood vessel malformations in a minimally invasive way. 

Penumbra JET 7 Xtra Flex Catheter Resource Center

What Happens After a Hemorrhagic Stroke?

Devastatingly, hemorrhagic strokes have a 51% to 65% mortality rate depending on the location of the bleeding in the brain. Of the patients who do survive the stroke, only 20% are expected to be independent within six months.  The journey to recovery of any sort from a hemorrhagic stroke is long and arduous. 

According to the National Stroke Association, 10% of people who have a stroke recover completely, and 25% recover with minor impairments. Almost 40% of people who have a stroke experience moderate to severe impairments which require special treatment to regain daily function at work or in personal life. Approximately 10% of patients require long-term care in a nursing home or other similar facility.

Rehabilitative Care After a Hemorrhagic Stroke

Stroke care focuses on helping patients regain as much function as possible in order to eventually return to living as independently as possible. However, it can be difficult to determine early on the amount of stroke care required since the impact of the stroke is determined by the area of the brain involved and the amount of tissue that was damaged. 

If the right side of the brain is harmed, movement and sensation on the left side of the body may be impacted. If the stroke damages the left side of the brain, movement and sensation on the right side of the body may be affected. Harm to the left side of the brain may also result in speech and language disorders. 

Rehabilitation occurs both at the hospital and once a patient is discharged. After discharge, rehabilitation will continue at one of the following locations: 

  • Rehabilitation unit in the same hospital 
  • Skilled nursing home separate from the hospital 
  • Patient’s home

Members of a patient’s stroke care team may include

  • Doctor trained in brain conditions (neurologist)
  • Rehabilitation doctor (physiatrist)
  • Rehabilitation nurse
  • Dietitian 
  • Physical therapist 
  • Occupational therapist 
  • Recreational therapist 
  • Speech pathologist 
  • Social worker or case manager
  • Psychologist or psychiatrist 
  • Chaplain 

Skill Recovery After Hemorrhagic Stroke

Strokes are considered to be a leading cause of serious long-term disability due to the probability of causing significant impairment in language, cognition, motor, and sensory skills. The goal of stroke rehabilitation is to improve skills that were lost as a result of the stroke. 

A stroke can cause a language impairment known as aphasia which creates general difficulty with speaking such as struggling to find the right words and challenges in speaking in full sentences. These issues can occur if the muscles that control speech were damaged in the stroke. Speech and language therapists can help to improve speech and language skills. If the damage is too severe to improve speaking skills, therapists can assist in developing other ways of communicating. 

Strokes can also inhibit thinking and reasoning abilities, lead to poor judgment, and cause memory and behavioral problems. Occupational therapists and speech and language therapists can assist in recovering these skills and help ensure that the patient’s home is a safe environment. 

A stroke can weaken the muscles on one side of the body and restrict joint movement. This results in decreased coordination and often makes walking difficult or leads to muscle spasms. Physical therapists can help patients learn how to balance and strengthen muscles again. 

Additionally, decreased sensory skills caused by strokes can decrease the body’s ability to feel sensory inputs such as heat, cold, or pressure.  Therapists can work to help patients adjust to these changes as well. 

Other complications that may also need to be treated include loss of bladder and bowel control, difficulty swallowing, and depression. 

GoldenbergLaw Can Help

If you or a loved one suffered a hemorrhagic stroke from a procedure where a Penumbra JET 7 Xtra Flex catheter was used, contact the Stroke and Brain Bleed Attorneys at GoldenbergLaw today for a free consultation. With over thirty years of experience, we will help you get the justice you deserve.