The Manta Vascular Closure Device And The Risks Of Its Usage

Introduction

The MANTA® Vascular Closure Device is manufactured by Essential Medical, Inc., and functions as a vascular closure device. Specifically, this device is designated for closure of large puncture sites in the large vessel of the leg; the femoral arterial access sites. A discrepancy in closing this artery can lead to many problems such as blood leakage and pooling.

This can lead to complications to the heart, impounding blood pressure problems as well as pooling itself can generate the small puncture to engross to a larger tear. The vascular closure device treats this possible discrepancy by proficiently closing the puncture with a bio-resorbable collagen plug and suture system. The Global Vascular closure device Market Size is predicted to reach $1,286 million with a growth rate of 6.8%. This illustrates the growing market since people across the world have a high prevalence of cardiovascular diseases, rising count of obesity and the increasing need for simple/practical vascular closure devices.

People who suffer from these conditions usually undergo a catheterization procedure, which the device is utilized afterwards. The MANTA® Vascular Closure Device first defines the access site and is determined by inserting the depth locator (.035 inch guidewire) until blood flow is detected on the outlet. By looking at the locator the deployment depth is calculated for device initiation. The MANTA sheath is inserted through the guidewire, the actual device is then inserted into the sheath. The device is pulled out until the calculated deployment depth is shown on the sheath.

In which the device is withdrawn from the puncture for the collagen plug and a biocompatible anchor to close the access site. These components are held by a suture and fixed by a “stainless-steel radiopaque” lock. Body absorption of the collagen plug and anchor will slowly occur, fully closing the puncture site. The device sizes are 14 Fr. and 18 Fr.; with these sizes the average elimination of blood flow at the site was 1 minute.

General Controls

The company Essential Medical Inc. provided varying general information about their company to the FDA. Essential Medical is a privately held company that was created by Greg Walters, a cardiovascular product specialist, and Gary Roubin, a coronary specialist. Created in 2010, Essential Medical Inc.’s objective was to create reliable blood vessel treating instruments and have the opportunity to commercialize their products to the community. In specifics their devices specialize and are all marketed towards vascular closure such as the MANTA. Their company resides in 260 Sierra Drive Suite 120 Exton, PA 19341. The MANTA is their only device on the market but this did not hinder their objective to commercialize their product. The reason is the company was bought by Teleflex, another medical device company, in October of 2018, before the FDA premarket approval of MANTA in 2019. Teleflex’s products range from interventional cardiology products to urology products in addition to others.

Medical Device Submission The MANTA® Vascular Closure Device is a Class III Device, due to its possible high risk of possible fallouts, since it is still inserted into the body and has to be procured by a professional. Vascular Closure Devices are not uncommon either. Mynxgrip, another device similar to MANTA, was marketed to be a Class II device in the FDA database but was withdrawn due to its compatibility with being one. The MANTA® Vascular Closure Device is a non-combination product classified under Device, Hemostasis, Vascular, MGB in the FDA database and was not granted an expedited review. The device pathway started with acute animal studies to observe the safety and evaluate the effectiveness of the device. These animal studies lasted from October, 2014 up to February, 2016. The premarket approval application for this device was received on July 9, 2018 and was reviewed by the Center for Devices and Radiological Health (CDRH) and Division of Cardiovascular Devices. Through the review the product was deemed to be safe and successful leading the product being approved on February 1, 2019. Today, clinical studies have shown that the device has a 97.7% success rate and a 5.3% complication rate.

FDA Clearance or Approval Response Letter

The FDA approval response letter was sent on February 1, 2019. The approval letter was motioned to Julie Broderick the Principal of Broderick Regulatory Consulting who worked for Essential Medical Inc. The letter outlined that the device was approved for commercial use if the FDA’s given conditions were applied. It was made clear that the device was to be utilized by trained practitioners and is limited to prescription only, under the Federal Good, Drug and Cosmetic Act. In accordance, it was contingent that expiration date was established.

To continue its approval periodic reports known as “Annual Reports” were to be made; discussing the amount distributed and sold to ensure the validity of the device. To continue justifying the validity of the device a non-clinical post-approval study was to be submitted at weeks 33, 48, and 57 concisely. Being a Class III device it was stated to provide a UDI on the device as well as annual reports. The letter finalized by discussing a PMA supplement was to be submitted.

Reflection

The MANTA® Vascular Closure Device is in a growing market that many people that undergo catheterization need. It underwent a journey of five years in order to be approved by the FDA. Which makes sense when trying to verify that a Class III Device is safe for the public to use and is able to get the most effective result. This device device went through a grueling process but it illustrates the provision the FDA provides in its role of adjudicating the reliability of medical devices to create a safer environment.

Insights Gained and Perspectives Formed When researching about a device’s trip through the FDA it gave me a new perspective about the FDA in general. The FDA works extremely hard in order for the general public to retain security among commodities such as these devices. Years go by in order for an approval to be even made. There are varying rigorous obstacles in order for a device to gain approval. Even with approval, strong regulations are placed to provide minimal to no risk to the people using the product. These regulations are annual reports, post approval studies, labeling etc. In contrast to what I believed before, I thought little of the FDA as my experience growing up was viewing them on commercial/advertised based drugs on the television. However, it is clear to see that the FDA imposes strict rules and consistent updates all in order to keep the consumers of the products safe and to validate the effectiveness of the device. I have gained new insight that the FDA is something not to the little of, it is what keeps our general well being thriving in the medical atmosphere.

Forensic Analysis

Background

HeartStart MRx Defibrillator is a medical device manufactured by Philips Electronics North America Corporation, and functions as an automated external defibrillator (AED). An automated external defibrillator acts to continue a regular heartbeat, possibly ceasing an irregular heartbeat or someone going under cardiac arrest. If not treated the user’s chances of survival drop exponentially by the minute. The way an AED works is that a computer within the device analyzes the intended applicant’s heart rate through electrodes. It determines whether a shock is needed and when determined, the deliverer is instructed through audio and visual cues by the device; electrodes send voltages to the body in order to reestablish normal heart rate. This procedure is to be used by trained medical personnel and if possible, the suggestion from a physician.

The HeartStart MRx Defibrillator is a Class III device, as it contains high risks when used improperly, since it can potentially exhibit a higher and multiple shocks through error. This would possibly lead to the death of the victim. The market for this is that in 2022 it is expected that the global defibrillators market would increase to $10,883.3 million by 2022. The target customers are people who have the potential of being a victim of sudden cardiac arrest. Since it is a highly recurring target disease, and is in need to be publicly accessible. Through all this though, problems still present themselves and this device recieved a Class I Recall.

Medical Device Recall

The recall of HeartStart MRx Defibrillator was ordered by Philips Electronics North America Corporation on February 8, 2018, because a defective component was discovered that shields the circuitry “from high voltages during shock.” It was also presently found that it could prevent the device from performing. People who contained the device from original and post-approval examinations were required to have their devices taken away. Even if people were not reported to have been harmed during this period the device still provided a high level of risk. The internal circuitry being damaged could sanction the device from working and could potentially function in alarming and dangerous ways through voltage shock. Since the problem was so greatly harmful the Philips Electronics North America Corporation issued this recall and classified it as a Class I recall, defined by causing serious damage and potentially death.

Corrective Actions The Philips Electronics North America Corporation corrective action started by sending a letter on June, 2017, RVO 2.0, Inc. sent its customers a letter notifying them of an “Urgent Medical Device Correction Notification/Field Safety Notice” (FDA). This letter detailed the problem occurring, hazards, and the measures to be taken. If their device is shown to be ineffective the company motioned for customers to report this. So that they can be contacted for their device to be replaced. If any questions still remained users were asked to communicate with their local Philips representative. Although there were only 71 units, it was not confined to the US these units were spread across the world making it harder to regulate and report on these devices in full effect. Through this trepidation, Philips Electronics and the FDA collaborated in handling the situation in a short and precise manner. Today, The Philips Electronics North America Corporation sells AEDs, commercialized with the help of the FDA.

Failure Modes (and Effects Analysis)

Failure modes for the HeartStart MRx Defibrillator are wide and varying. cinclude worsening vision problems relating to glare and pain. In the FDA database AEDs were reported to have 100 different problems. The main serious problem dealt with the device operating in an unexpected way which was reported 5625 times. This would cause great risk to the victim; potentially losing a life. Another prevalent issue is the inability to power up (3967 reports). Where in a life saving situation would render the victim to result in dieing.

Finally, the device can display an incorrect message making it difficult for the rescuer to use the device not knowing if the procedure should be taken. Failure is much caused by system error and not patient/human error. In the database the 100 problems have to deal with a circuitry problem leading to multiple counts of failure. It is not something that should not be as prevalent as it is treating the heart. The failure of this device could lead to a multitude of harm to the patient and evidently death. The device was portrayed as unsafe by the FDA at the time and the way to have prevented this outcome was to run multiple tests. Running tests that would calculate the voltage exhibited from the device at a constant rate. As well as appointing a periodical device check, thoroughly analyzing the wiring and electrodes of the product.

Personal Reflection

While defibrillators are a key part in the medical society, this particular AED contained many problems due to it having multiple recalls in a small time period. The clinical trials performed before were displayed to be safe and effective however when commercialized the device catalyzed hazards that were unforeseen by the company. Observing this, Class III devices especially an AED should be tested in a lengthened setting and having more rigorous trials to ensure the safety of the victim and the reliability of the product itself. The identified Device Failure showed that there was a “Noncomforming component,” that independently led to possible harm.

To avoid this rechecking coding and the electronics of the device before distribution should be applied, and possibly a redesign of the product. If the design of the product was able to calibrate in a quicker setting while maintaining the simplistic value of the product. The deliverer would be able to quickly determine whether the device is safe upon shock voltage; if not safe another AED or a normal defibrillator could be put into use. Another way it could be redesigned would be easy access to assess the properties and mechanisms of the device in order to maintain the product’s reliability.