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The Medtronic HawkOne lawsuits claim the Medtronic HawkOne Directional Atherectomy System’s catheter can break apart and cause patients to suffer injury, including arterial dissection, arterial rupture, ischemia, and/or blood vessel complications.
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In December 2021, Medtronic initiated a recall of 95,110 HawkOne Directional Atherectomy Systems. The recall involves devices distributed from January 22, 2018, to October 4, 2021.
The U.S. Food and Drug Administration (FDA) posted the recall on January 19, 2022, and followed up with an update classifying the recall as a Class 1 recall—the most serious type. This is a classification the FDA reserves for situations that present a risk of severe, life-threatening injuries or deaths.
Medical professionals use the HawkOne Directional Atherectomy System to help eliminate blockage from peripheral arteries. The device includes a catheter and a cutter driver.
Unfortunately, the catheter’s guidewire can prolapse and move down upon the application of force. This can lead to the catheter tip detaching, potentially resulting in serious adverse events, such as:
Although the FDA states that no deaths had been reported at the time of the recall, the agency’s adverse event reporting system showed fifty-five reports of injuries connected to the HawkOne.
Recall of the Medtronic TurboHawk Plus Directional Atherectomy System
On February 4, 2022, Medtronic also initiated a recall of its TurboHawk Plus Directional Atherectomy System. This recall, also classified as a Class I recall, affects devices manufactured from July 21, 2021, to November 25, 2021, and distributed from September 27, 2021, to January 25, 2022.
According to the FDA’s posting, 686 devices were recalled in the U.S. No injuries or deaths associated with the TurboHawk system had been reported as of February 7, 2022.
Medtronic recalled the devices because they shared a similar design to the HawkOne system, thereby increasing the risk of similar poor outcomes.
How These Devices Were Approved
The FDA approved the 510(k) applications of the HawkOne and the TurboHawk Plus Directional Atherectomy Systems based on the devices being at least as safe and effective as existing, legally marketed devices in the U.S. This type of approval gives companies like Medtronic the green light to fast-track product development without the added safeguards of clinical trials and more rigorous oversight.
The HawkOne is credited with giving Medtronic control of 90% of the global market share for directional atherectomy devices used in peripheral artery disease (PAD) interventions, according to Medical Device Network.
Prior to the launch of the TurboHawk Plus, HawkOne had earned a spot as the device of choice for these procedures. The TurboHawk and SilverHawk systems—earlier product offerings in Medtronic’s portfolio—experienced several recalls. For the most part, the TurboHawk was phased out after Medtronic rolled out the TurboHawk Plus. The medical industry anticipated this release was engineered to expand the company’s global presence.
If the guidewire of either the HawkOne or TurboHawk Plus Directional Atherectomy Systems prolapses, the catheter tip may break or separate and cause a range of serious injuries, such as the following:
Arterial Dissection
John Hopkins Medicine describes arterial dissection as an “abnormal, and usually abrupt, formation of a tear along the inside wall of an artery.” The tear allows blood to leak between the three layers of different types of tissue in the artery wall and separate them.
Cleveland Clinic describes the effect as similar to what happens when a piece of plywood gets wet. A “false lumen” or small pouch begins to develop as the tear increases in size. As blood gathers inside the pouch, blood clots can form. The pouch itself can impede the flow of blood. In either case, the potential for stroke increases. Doctors typically treat this condition with blood thinners (warfarin or low molecular weight heparin) for a three- to six-month period.
Arterial Rupture
A ruptured artery can put a patient in extreme danger. This is especially true if the largest artery—the aorta—suffers the rupture. The aorta, which carries oxygenated blood from the heart, can rupture when an aortic aneurysm ruptures. Pressure within the aorta is understandably high, given its role of connecting blood pumped from the heart to the rest of the body. The profuse bleeding that follows this rupture can very easily and just as quickly lead to shock and even death.
Ischemia
When an artery is blocked, blood flow is restricted. This reduces or restricts the flow of oxygen to parts of the body. There are different types of ischemia, each with the potential of serious injury to the patient. Ischemic stroke, for example, results from blockage in the artery that transports oxygen-rich blood to the brain, according to the National Heart, Lung, and Blood Institute (NHLBI).
The NHLBI further explains that within minutes of a blockage preventing oxygen flow to the brain, the brain cells start to die. A patient who suffers a stroke can endure long-term disability, lasting brain damage, or even death.
Blood Vessel Complications
Vascular injuries such as those that could result from a broken or detached catheter tip, can cause a wide variety of complications. These include a heightened risk of stroke, heart attack, heart disease, and heart failure.
A Medtronic HawkOne or TurboHawk Plus settlement can cover a broad range of compensation for injured patients, including:
October 14, 2016: FDA notifies Medtronic the agency has approved the Medtronic HawkOne device under the “fast track” 510(k) process.
December 6, 2021: Medtronic initiates the HawkOne Directional Atherectomy System recall by sending an Urgent Medical Device Notice warning of risks associated with guidewire prolapse caused tip damage.
August 24, 2021: FDA announces approval of the 510(k) application of Medtronic’s TurboHawk Plus Atherectomy System, an updated version of an older device that had been, for the most part, phased out.
January 19, 2022: FDA posts a recall of the Medtronic HawkOne Directional Atherectomy System.
January 21, 2022: FDA classifies the TurboHawk Plus recall as a Class I recall because of the risk of serious injury or death.
February 4, 2022: Medtronic initiates the TurboHawk Plus Directional Atherectomy System recall by sending an Urgent Medical Device Notice warning of risks associated with guidewire prolapse-caused tip damage.
March 11, 2022: FDA issues an update on the TurboHawk Plus recall, classifying it as a Class I recall because of the risk of serious injury or death.
The HawkOne Directional Atherectomy System is used to remove blockages from peripheral arteries and improve blood flow, according to the Medtronic website.
The device uses a catheter and a cutter driver to cut through plaque in patients who suffer from peripheral arterial disease. Medtronic positions the device as one designed to treat all plaque morphologies. The company suggests the device is the right choice for medical professionals who aim to “preserve their patients’ native vessel” and maintain options for future treatment.
The TurboHawk Plus Directional Atherectomy System is intended to meet the same purpose.
This randomized study explores plaque removal and luminal gain from using CSI’s DIAMONDBACK 360 ® Peripheral Orbital Atherectomy System as compared with Medtronic’s HawkOne Directional Atherectomy system. Researchers will collect the clinical data at baseline, immediately before the procedure, during the procedure, and immediately following the procedure, as well as within 30 days and six and 12 months after the procedure. Ninety subjects will be enrolled in the trial plan with a study duration of around two years. To read more, click ClinicalTrials.gov
In November 2014, Covidien (now Medtronic) presented the one-year results of the DEFINITIVE AR study. This study aimed to identify the clinical benefits of using directional atherectomy for plaque removal followed by treatment with a drug-coated balloon. The TurboHawk and SilverHawk were used in the study. To read more, click Endovascular Today
The purpose of this study was to identify the extent and therapeutic consequences of spontaneous intracranial artery dissection (IAD) at the acute phase of ischemic stroke. To read more, click Journal of NeuroInterventional Surgery
This study aimed to describe the clinical characteristics of cerebral artery dissections in children. Researchers found a marked male predominance among children with arterial dissections that were not explained by trauma. Most childhood instances were intracranial. The vertebral artery that is most susceptible to dissection was similar to that of adults. To read more, click Neurology
This report explores a case of traumatic subclavian arterial rupture resulting from blunt chest trauma after a four-meter (thriteen foot) fall. To read more, click World Journal of Emergency Surgery
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