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Pipeline Flex Embolization Device Lawsuit Update: Medtronic’s Pipeline Flex Recall is Class I
June 11, 2020: The FDA has issued a Class I recall of the Medtronic Pipeline Flex embolization device and the Pipeline Flex embolization device with shield technology.
The company manufactured the affected products from Oct. 22, 2019, to Feb. 1, 2020, and distributed them between Nov. 6, 2019, and Feb. 7, 2020. In total, Medtronic has recalled 822 devices in the U.S.
Medtronic discovered the potential for fracture at the distal section of the instruments due to a weakened bond in a subset of recently manufactured devices. Use of the affected product could result in unintended separation, where the distal portion of the device delivery system remains in the patient. This could lead to significant patient injury, ischemic stroke, intracranial hemorrhage, neurological deficit, and/or death.
Users are urged to cease the use of any affected products and return them to Medtronic. If an alternative is needed, a Medtronic representative can assist with finding a suitable replacement
Medtronic issued a recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology in February of 2020, citing risks that the systems can fracture while being placed inside of patients. These fractured pieces can stay inside of patients’ bloodstreams leading to worsened conditions and other serious adverse health effects such as blocked blood vessels, stroke, and death. The U.S. Food and Drug Administration labeled the decision a Class I Recall, the most serious of FDA recalls. If you or a loved one received a Medtronic Pipeline Flex Embolization Device and subsequently suffered serious health injury associated with the device, you may be eligible to participate in a Medtronic Pipeline Flex Embolization Device lawsuit. Contact an experienced Medtronic Pipeline Flex Embolization Device lawyer from TorHoerman Law to discuss your legal options, or get an instant case evaluation online now.
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.
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 can treat brain aneurysms for patients who are 22 years and older. The device and surgery is used to treat brain aneurysms including:
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.
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:
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 at the FDA website.
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. Read more about the field safety notice at MassDevice.com.
The FDA approved of 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 at 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.
The Medtronic Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology recall was 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:
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:
For patients who have already had a Pipeline Flex Device successfully implanted, there is not an increased risk of complications or injuries.
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:
Medtronic advised customers with questions to contact Medtronic Quality Assurance at 1-800-633-8766 or at email@example.com.
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.
If you or a loved one suffered from a Medtronic Pipeline Flex Embolization injury or death, you don’t have to fight alone. It is likely you are 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 – 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.
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.
February 7, 2019: According to Medtronic, its Pipeline Flex embolization device is now indicated for patients with small or medium, wide-necked brain aneurysms. The device was previously cleared for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms, Medtronic said.
Clearance came based on data from the 141-patient PREMIER trial of the device, which reported a one-year occlusion rate of 76.7% with the use of 1.1 device per subject on average. The study also reported an average 2.2% rate of major stroke or neurological death, according to the company.
The Pipeline Flex device is designed to divert blood away from aneurysms. The tool features a braided cylindrical mesh tube which cuts off blood flow and reconstructs the diseased section of the parent vessel.
“Working hand-in-hand with physicians to develop new technology and clinical data is at the core of our mission. The Premier study not only demonstrated excellent safety and efficacy outcomes but also delivered on our commitment to broadening access to innovative therapies for new groups of patients requiring aneurysm treatment,” neurovascular biz GM Stacy Pugh said in a press release.
Center for Devices and Radiological Health. “Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk.” U.S. Food and Drug Administration, FDA, 2020, www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-pipeline-flex-embolization-devices-due-risk-device-fracture?utm_campaign=FDA%2BMedWatch%2B-%2BPipeline%2BFlex%2BEmbolization%2BDevices%2Bby%2BMedtronic%3A%2BClass%2BI%2BRecall&utm_medium=email&utm_source=Eloqua.
Center for Devices and Radiological Health. “Pipeline Flex Embolization Device - P100018/S015.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/recently-approved-devices/pipeline-flex-embolization-device-p100018s015.
Densford, F. (2019, February 7). FDA expands indications for Medtronic's Pipeline Flex embolization device. Retrieved from https://www.massdevice.com/fda-expands-indications-for-medtronics-pipeline-flex-embolization-device/
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) PipelineTM Embolization Device. U.S. Food and Drug Administration, 2011, www.accessdata.fda.gov/cdrh_docs/pdf10/P100018B.pdf.
Whooley, Sean. “Medtronic Issues Urgent Field Safety Notice for Some Pipeline Flex Embolization Devices.” MassDevice, 4 Mar. 2020, www.massdevice.com/medtronic-issues-urgent-field-safety-notice-for-some-pipeline-flex-embolization-devices/.
Last Modified: June 11th, 2020 @ 11:25 am
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