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TIVAD Lawsuit

TIVAD Lawsuit

Totally Implanted Ports, also known as TIVAD Ports, can cause serious injuries or death when they leak medication, become infected, or break inside the body.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting TIVAD Port induced injury cases in all 50 states. If you or somebody you know has been injured when a TIVAD Port broke, leaked, caused an infection, needed surgery, or other serious complication, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

TIVAD Lawsuit Claims it Can Leak Medication

A lawsuit has been filed by the family of a cancer patient who was injured after his TIVAD port broke and leaked chemotherapy medications into his body.

What Happened?

The TIVAD lawsuit was filed by the family of Jesus L. III, a young man from Concho County, Texas, who died in May 2021 after years of cancer treatment.

According to the lawsuit, he was implanted with an AngioDynamics Vortex Port in June 2019 at Texas Children’s Hospital in Houston, Texas, for chemotherapy.

Less than two weeks later, he had to undergo another surgery to remove the Vortex port after it broke. Doctors discovered that it was leaking chemotherapy medication under his skin around the port.

Why Are Vortex TIVAD Ports Leaking?

The Vortex Port is also known as a Totally Implantable Venous Access Device (TIVAD), which consists of a silicone port under the skin that is attached to a long tube called a catheter that goes directly into a vein.

The catheter is made of silicone mixed with barium sulfate, so it can be seen on an X-ray. The problem is that barium sulfate can reduce the strength of silicone over time, which can cause it to break or leak.

Leaks from Defective Locking Mechanism

The locking mechanism between the port and the catheter can also leak. The lawsuit claims that AngioDynamics was “on notice of a design defect in the Vortex which caused the failure of the locking mechanism which secures the catheter to the stem of the injection port.”

Due to this design defect in the locking mechanism, “the Vortex has an increased risk that the catheter will separate from the injection port, causing medication and administered fluids to leak into the tissue of the port implantation site,” according to the lawsuit.

TIVAD Ports Linked to Serious Injuries & Deaths

The lawsuit alleges that soon after the Vortex was introduced to the market, AngioDynamics and Navilyst began receiving reports of the Vortex Port breaking after it was implanted — and the fractured pieces were migrating throughout the body, including to the heart and lungs.

Lawsuits claim that there were also large numbers of reports of the Vortex leaking, fracturing, and perforating internal veins. These failures were often associated with reports of severe injuries, such as:

  • Hemorrhage (internal bleeding)
  • Cardiac / pericardial tamponade
  • Cardiac arrhythmia and symptoms similar to a heart attack
  • Severe and persistent pain
  • Perforations of tissue, vessels and organs
  • Death

Can Doctors Safely Remove Vortex TIVAD Ports?

Despite the risk of serious injuries, the lawsuit claims that AngioDynamics failed to design a safe way to remove the Vortex port. Therefore, “in the event of a failure, injury, or complications, it is difficult to safely remove the Vortex.”

Other Serious Injuries Linked to TIVAD Ports

  • Breakage of the TIVAD device
  • Leaking medication and fluids into the body (called “extravasation”)
  • Infection
  • Sepsis
  • Erosion of the TIVAD through the skin
  • Hemorrhage (bleeding)
  • Cardiac / pericardial tamponade (pressure around the heart) due to fluid leaking
  • Cardiac arrhythmia
  • Cancer advancement when the TIVAD breaks or leaks medication, which reduces the effectiveness of chemotherapy
  • Necrosis (death of body tissue from lack of blood-flow)
  • Perforation of tissue, blood vessels, or organs
  • Wound coming apart
  • Removal surgery
  • Death

Overview: What is a Totally Implanted Port?

Patients who need long-term treatment with intravenous (I.V.) medicines or fluids may be implanted with a Totally Implanted Venous-Access Device (TIVADs), also called “Totally Implanted Ports” or Port-a-caths.

TIVADs make it easier for doctors and nurses to deliver medications directly into a patient’s bloodstream. The device is surgically implanted completely under the skin, and left implanted, providing healthcare professionals with quick access to a patient’s vein.

How Does a TIVAD Work?

The TIVAD consists of an a silicone injection port that is connected to a long hollow tube (called a “catheter”). One end of the tube sits in a big vein, and the other end of the tube is attached to an injection port that is located just under the patient’s skin, usually on their arm or chest. Doctors insert a needle through the skin into the TIVAD Port to deliver blood, fluids, medication, or nutrients directly into the patient’s veins.

Advantages of a TIVAD

Because a TIVAD is implanted completely inside the body, it is invisible and does not require frequent dressings and medical care. This is an advantage for patients who have medical conditions that need repeated I.V. access for months or years.

Another advantage is that the medication can be delivered to a larger vein, which is especially helpful for chemotherapy drugs that would otherwise damage and irritate the smaller veins, causing serious pain.

What is a TIVAD Used For?

TIVADs are commonly implanted for several reasons:

  • Cancer patients who need long-term chemotherapy treatments
  • Veins that are hard to access repeatedly
  • Patients who are suffering from painful veins due to intravenous chemotherapy
  • Patients who need repeated blood samples, parenteral nutrition, blood transfusions, or other intravenous medications

Types of TIVAD Ports

  • BioFlo Port by Angioflow
  • Vortex Port by Angioflow
  • Power Port by Bard
  • XCELA
  • Navilyst / Angiodynamics
  • Medcomp
  • Dignity Low Profile CT Ports
  • Duo Power Port by Bard
  • Palpation Points

Hospital Discontinues Palpation Points Port for Erosion Risk

In 2018, a presentation by the Department of Radiology at Massachusetts General Hospital warned that Palpation Point Ports were not being placed due to a “high incidence of erosion.” As an example, the presentation included photos of two patients with failed TIVAD ports.

Power Port Duo Recalled for Breakage (2021)

In 2021, Bard issued a Class II recall for certain Power Port Duo M.R.I. Implantable Ports because they can break in the body and cause other complications. “Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements,” according to the Power Port Recall notice to healthcare professionals.

Cook Medical Recalls 31,000 Vital-Port for Leakage Risks

In November 2017, Cook Medical issued an Urgent Medical Device Recall after determining that 31,000 Vital-Port Vascular Access Systems could leak medications or cause life-threatening injuries.

The problem is that during implantation, a needle provided with the Vital-Port could accidentally cut a piece of silicone out of the Vital-Port septum.

According to the warning from Cook Medical, these silicone pieces could “embolize into the patient’s bloodstream. In addition, medications may leak from the port, resulting in inadequate delivery of the medication and potential injury to the surrounding tissues.”

In March 2018, Cook Medical announced a Class II recall for the Vital-Port Vascular Access Systems. No injuries were reported.

TIVAD Class Action Lawsuits

The Schmidt Firm, PLLC is nationally recognized as a class action law firm. We are filing individual TIVAD lawsuits for people who were injured or died from complications of defective TIVAD Port.

If you or a loved one was harmed, we may be able to help you file a lawsuit against the manufacturer, seek justice and financial compensation for your injury, medical expenses, permanent injuries, lost income, wrongful death of a loved one, and more.

Do I have a TIVAD Lawsuit?

The Schmidt Firm, PLLC is currently accepting TIVAD Port induced injury cases in all 50 states. If you or somebody you know has been injured when a TIVAD Port broke, leaked, caused an infection, needed surgery, or other serious complication, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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