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Medtronic Pipeline Flex Embolization Device Adverse Event Reports

According to Medwatch, the FDA Safety Information and Adverse Event Reporting Program, there have been 50 medical device reports of Medtronic Pipeline Flex Systems fracturing from November 1, 2019, to March 1, 2020. Of the reports, there have been 10 injuries and 1 death. Patients who already have a Pipeline Flex Embolization Device successfully implanted are not at increased risk. TorHoerman Law is exploring possible Pipeline Flex Embolization Device lawsuits. If you or a loved one suffered from a Pipeline Embolization Device injury or death, contact us to learn more about your potential case.

 

What is a Pipeline Flex Embolization Device?

A Pipeline Flex Embolization Device, or “Pipeline Flex,” is a permanent stent used to treat brain aneurysms. The Pipeline Flex stent is made up of braided platinum, tungsten, and cobalt-chromium-nickel alloy wires. A guidewire-based delivery system is used to implant the device inside of patients.

 

Pipeline Flex Embolization Surgery

Pipeline Flex embolization surgery can treat brain aneurysms for patients who are 22 years and older. The device and surgery are used to treat brain aneurysms including:

  •  Small or Medium Wide-Neck Aneurysms: neck width 4 mm or wider, dome-to-neck ratio 2 or less
  • Saccular or Fusiform Aneurysms: spindle-shaped, elongated aneurysms that involve the entire vessel
  • Internal Carotid Artery Aneurysms: vessel diameter from 2 – 5 mm
  • Large Wide-Neck Aneurysms: in certain internal carotid artery regions

Pipeline Flex surgery has proven to be an effective brain aneurysm treatment. In a clinical study of 134 patients treated with a Pipeline Flex device, 79.98 percent of them had complete occlusion of their aneurysm within a one-year period. None of these patients required re-treatment or restenosis.

 

Pipeline Flex Embolization Recall

The Medtronic Pipeline Flex Embolization Device recall has been in effect as of February 14, 2020. It is a Class I Recall, meaning the use of the devices could lead to serious injuries or death. Per the FDA Website:

Recalled Product:

  • Pipeline Flex Embolization Device (Available in the US) and Pipeline Flex Embolization Device with Shield Technology (Not Available in the US)

 

Product Codes:

  • Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350 -XX, PED-375-XX, PED-400-X
    PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX
  • Pipeline Flex Embolization Device with Shield Technology: PED2-250-XX, PED2 -275-XX, PED2-300-XX, PED2-325-XX, PED2 -350-XX, PED2-375-XX,
    PED2-400-XX, PED2 -425-XX, PED2 -450-XX, PED2-475-XX, PED2-500-XX

 

Manufacturing Dates: October 22, 2019, to February 1, 2020

 

Distribution Dates: November 6, 2019, to February 7, 2020

 

Devices Recalled in the U.S.: 822

 

Date Initiated by Firm: February 14, 2020

 

Learn more about FDA Pipeline Flex Embolization Device Recall.

 

Medtronic Field Safety Notice

Medtronic issued an urgent field safety notice regarding its Pipeline Flex Embolization Devices. The Minnesota-based company warned that the devices could potentially fracture and leave remains inside of patients. This unintended separation can lead to significant adverse effects such as ischemic stroke, extended procedure, intracranial hemorrhaging, neurological damage, and even death.

The company noted in the field safety notice that if a patient already has a successfully implanted embolization device, there is not an increased risk, and those patients can continue with normal treatment. Medtronic urged any patients affected by the devices’ fracturing to immediately stop using the affected products. The company said healthcare professionals should remove and quarantine any unused devices and return them to Medtronic.

Medtronic officials said that the affected lot of devices include any with a “use-before” date from on or after October 21, 2022. The field safety notice said the company has not received complaints about issues from the affected population.

 

Is the Pipeline Flex Embolization Device FDA approved?

The FDA approved the Pipeline Flex Embolization Device (P100018/S015) on December 14, 2018. Full information about the product and the basis for its approval can be found in the Summary of Safety and Effectiveness Data (SSED). In February of 2019, Medtronic won expanded FDA approval for additional use of its devices. However, the FDA issued a Class I Recall (the most serious recall) in February 2020. Medtronic recalled its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to risks of the delivery systems fracturing inside of patients.

 

Who is Affected by the Device Recall?

The Medtronic Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology recall were initiated to protect patients and healthcare providers. There are risks the systems can fracture while providers place the stent inside of patients. Those who might be affected are:

  • healthcare providers using the Pipeline Flex device to treat brain aneurysms
  • any patient groups undergoing procedures that involve the Pipeline Flex Embolization Device or Pipeline Flex Embolization Device with Shield Technology

 

What should Patients and Providers Do?

Medtronic alerted its customers with an Urgent Medical Device Recall Notice regarding the affected Pipeline Flex Devices. Affected devices include any product manufactured between October 22, 2019, to February 1, 2020, and any devices distributed from November 6, 2019, to February 8, 2020. The recall included the following instructions:

  • Do not use any affected devices. Remove and quarantine all unused affected products.
  • Return the affected products to Medtronic. Medtronic representatives will assist in facilitating the returns if needed. They can also assist in identifying suitable replacement devices.
  • Complete the Medtronic Customer Confirmation Form and share it with the Medtronic team.
  • Share the company’s recall notice with all organizations impacted by the affected products.
  • Be aware that Medtronic has taken all necessary steps to stop the future distribution of the affected products.

Medtronic advised customers with questions to contact Medtronic Quality Assurance at 1-800-633-8766 or rs.nvcomplaints@medtronic.com.

 

Pipeline Flex Embolization Injuries & Complications

As of March 2020, the FDA had received 50 medical device reports over the Pipeline Flex systems that included 10 injuries and one death. There is a risk with these devices that the delivery system can fracture inside of a patient. If this happens, the following can occur:

  • worsening of the patient’s condition
  • continued blockage of blood vessels
  • stroke
  • death

For patients who have already had a Pipeline Flex Device successfully implanted, there is not an increased risk of complications or injuries.

 

How Do I Report a Problem or Injury?

Consumers and healthcare professionals can report “adverse reactions of quality” problems to Medwatch: the FDA Safety Information and Adverse Event Reporting Program by mail, FAX, or online form.

 

Filing a Pipeline Flex Embolization Device Lawsuit

If you or a loved one suffered from a Medtronic Pipeline Flex Embolization injury or death, you don’t have to fight alone. You are likely eligible for product liability or defective product lawsuit. It’s important to take the proper steps in filing your Pipeline Flex Embolization Device Lawsuit.

The first of, and one of the most important, steps you should take is mitigating your injuries. This involves seeking immediate medical care, diagnosis, and treatment. Mitigation is important for your health and the strength of your case.

You should then hire a personal injury lawyer to act as your Pipeline Flex Embolization Device lawyer. Do your due diligence when seeking legal representation, but do not wait too long to take this initial legal step – the statute of limitations limits the amount of time that you have to take legal action after an injury has occurred.

After hiring a Pipeline Flex Embolization Device lawyer, you should familiarize yourself with the steps of civil litigation,so you know have some idea of the process of a Pipeline Flex Embolization Device lawsuit.

It’s also crucial to gather evidence including any necessary documents, bills, photos, and records.

Your Pipeline Flex Embolization Device lawyer will help you to assess damages and make a claim against the party that holds liability for your losses. In this case, liability will fall on the manufacturer, Medtronic. However, depending on the circumstances, other parties could also hold some liability. In many product liability lawsuits, the plaintiff will choose to make a demand for both compensatory damages and punitive damages.

Your attorney will work to win you compensation for your losses either through a pretrial settlement or in a Pipeline Flex Embolization Device lawsuit trial.

 

Hiring a Pipeline Flex Embolization Device Lawyer

TorHoerman Law is exploring a possible Pipeline Flex Embolization Device lawsuit. Our firm specializes in a variety of product liability lawsuits including defective products. We will work with you to navigate the legal system and help you build the best case possible. We offer free, zero-obligation case consultations for all potential clients. We also work on contingency fees, meaning we don’t charge our clients until they have received compensation. Contact a Pipeline Flex Embolization injury lawyer at TorHoerman today to learn about your potential case and legal options.

 

 

 

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