Abbott Recalls Trifecta Heart Valves From U.S. Market Amid Concerns About Early Deterioration Problems
Withdrawal comes after FDA warning that problems with Trifecta heart valves have been linked to nearly 200 patient deaths due to early deterioration
Following an FDA warning issued earlier this year about early deterioration problems with Trifecta heart valves, which have been linked to nearly 200 patient deaths since 2011, Abbott Laboratories has announced that it is removing the controversial valves from the market and recalling any remaining devices that medical providers still have in inventory.
In a letter (PDF) sent to customers on July 31, Abbott announced that it is discontinuing the Trifecta family of values, including the Abbott Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT). The manufacturer also indicated that it will collect unused devices from the field.
The recall comes nearly six months after the FDA first posted information about potential Abbott Trifecta Valve deterioration risks, urging individuals with the device to seek immediate medical attention if they experience shortness of breath, fatigue or other new symptoms. In addition, doctors were asked to ensure life-long follow up visits are conducted, at least once per year, to monitor for signs of early structural valve deterioration (SVD).
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FIND OUT IF COMPENSATION IS AVAILABLETrifecta Heart Valve Premature Deterioration Problems
The first generation model of the Trifecta valve was approved by the FDA in 2011, and the Trifecta GT valve was introduced in 2016. The valves are a type of prosthetic designed to treat individuals with diseased, damaged, or malfunctioning aortic heart valves, which play a crucial in the circulatory system, controlling the flow of oxygen-rich blood from the heart to the rest of the body.
In certain conditions, such as aortic stenosis (a narrowing of the aortic valve opening) or aortic regurgitation (a condition where the aortic valve doesn’t close tightly), the aortic valve does not function properly. For these individuals, doctors may recommend removing the patient’s original aortic valve and replacing it with a prosthetic.
Although the Trifecta valves were marketed as safe and effective, the devices have been associated with nearly 3,000 adverse events since 2011, including over 2,100 reported injuries and, 191 deaths.
These problems led the FDA to issue warnings to healthcare providers in February 2023, citing recent data that suggested the Trifecta valves are at risk of deteriorating within five years, with most problems appearing between three and four years after being implanted.
SVD is a known problem which can affect artificial heart valves, causing the aortic valve to narrow leak, or both, often leading to the need for further surgery. However, the FDA warned that the Trifecta valve deterioration rate, and the need for surgical intervention, was much higher than other heart valves on the market.
Abbott Trifecta Valve Recall Could Have Come Earlier
In the letter sent to customers this week, Abbott indicates that it decided to discontinue the Trifecta valves to focus on tissue heart valve solutions that maximize the possibility for lifetime management of valvular heart disease. However, the manufacturer may now faces serious questions about why it failed to issue a Trifecta valve recall earlier, or adequately disclose information about the early deterioration as soon as it was discovered.
The same day Abbott asked customers to remove unused devices, the FDA posted an update on it’s website, indicating that the agency’s recommendations for individuals implanted with a Trifecta valve has not changed. However, the FDA noted that it will continue to work with Abbott to evaluate the risk of early structural valve deterioration with devices already implanted, and keep the public informed if there are any new recommendations or regulatory actions.
The affected Trifecta valves and model numbers include; TrifectaTM Valve and TrifectaTM Valve with Glide Technology Model: TF-19A, TF-21A, TF-23A, TF-25A, TF-27A, TF-29A, TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, and TFGT-29A.
In the coming weeks, the FDA may decide to classify the voluntary market withdrawal as an Abbott Trifecta Heart Valve recall, to make sure the public and healthcare providers understand the potential risks that may result from continued use of the devices.
Given the widespread problems linked to the device in recent years, it is also possible the manufacturer will face substantial liability from Abbott Trifecta Heart Valve lawsuits brought on behalf of individuals who experienced complications following early deterioration of the valve.
5 Comments
JohnSeptember 9, 2024 at 1:20 pm
I was born with a bicuspid aortic valve and went to the Cleveland clinic and they had just switched over to the new St Jude trifecta from the Edward sabian it was 2013 I had to have that valve put in me and was tired ever since I had to stop working driving a truck because I was always too tired I had shoulder replacement 2022 and found out through an echo cardiogram that my valve was stiffening. [Show More]I was born with a bicuspid aortic valve and went to the Cleveland clinic and they had just switched over to the new St Jude trifecta from the Edward sabian it was 2013 I had to have that valve put in me and was tired ever since I had to stop working driving a truck because I was always too tired I had shoulder replacement 2022 and found out through an echo cardiogram that my valve was stiffening. The valve is a TF 27a. I found out I need to have it replaced that I was never notified that the valve was recalled in October of 2023. They have known about this problem for years in the meantime I have been suffering from fatigue and unable to do much of anything but sleep
MitchellMarch 14, 2024 at 7:42 pm
I had a tf-21a implanted in me in 2015. only by accident in November 23 i was in the hospital for a kidney stone. that day they told me My valve was severely leaking. At that point i went to my cardiologist and he confirmed. i had a second echo and it confirmed . I then went to cornell university hospital and saw a great surgeon and he said it should be replaced. I then went home that night and [Show More]I had a tf-21a implanted in me in 2015. only by accident in November 23 i was in the hospital for a kidney stone. that day they told me My valve was severely leaking. At that point i went to my cardiologist and he confirmed. i had a second echo and it confirmed . I then went to cornell university hospital and saw a great surgeon and he said it should be replaced. I then went home that night and looked up my valve and it was a tf-21a. At that point I made the schedule to replace it march 25 2024. Thereafter i called a few law firm about the lawsuit i had been reading about. and after providing them a ton of material from my hospital letter from abbott labs. they call me back to tell me they did not want my case. They did not want it cause i did not show and damages yet! although I did have a stroke, tired, etc. I said why wait people are dying from this valve. don't they read article on the thousands that are effected and 191 died from failure. I want it out of me!!!!! And the Hospital Valley hospital in ridgewood NJ did not sent out a warning after one years. I called them and they don't want to take responsibility for doing that they blame abbott lab to. Well Valley hospital abbott sent letter to you. i can imagine i was lucky to find out by being in the hospital in November sorry for all the other that don't know. This is a failure of responsibility on the hospital part to inform there customer and the women said to me in public relation said " What do you want us to do Mr Cooperman" i said how about a apology first of all. And she hung up. i can go on about this failure of the FDA, Abbott and Valley hospital, i think the failure is to on these attorney who only want perfect cases so they can win. Let me ask you Mr attorney, If mercedes sent you a letter saying " we have a possibility of brake failure in your car that you bought on the backs of personnel injury would you drive the car until you got into accident and god forbid someone died or have it fixed right away" Well that is what I doing!!!! Is anyone else going through this. Mitch
RickFebruary 27, 2024 at 2:00 pm
I had one of these Trifecta GT Tissue Heart Valves put into me in July of 2000. It's a long story but new negative symptoms (shortness of breath, fatigue, weakness, headaches) arose after this replacement that altered my life since. Last week I started getting chest pains, went to the ER, and they found that my Trifecta valve had torn. This was only after 3-1/2 years of use. They did another h[Show More]I had one of these Trifecta GT Tissue Heart Valves put into me in July of 2000. It's a long story but new negative symptoms (shortness of breath, fatigue, weakness, headaches) arose after this replacement that altered my life since. Last week I started getting chest pains, went to the ER, and they found that my Trifecta valve had torn. This was only after 3-1/2 years of use. They did another heart surgery to replace this Trifecta product with a new Pericardial device. I am now much better but have lost 3-1/2 years of my life - not being able to do things (travel, golf, running) I normally would do. I want some sort of compensation from Abbott Labs for the suffering I have gone through over these past few years. By the way, I don't know why, but I have lost over 60 pounds since that 2000 replacement. I am nothing but skin and bones now.
RobertFebruary 22, 2024 at 2:22 pm
On February 25, 2019 I had my Aortic valve replaced due to Aortic Stenosis, They used The Trifecta valve. November 29, 2023 I had to have a TAVR procedure due to severe Aortic Stenosis. The first valve didn't even last 5 years.
RickJanuary 5, 2024 at 8:51 pm
I had one of these Trifecta GT valves put in me in July of 2020. I never felt well after that surgery and I told my cardiologist over and over again about this. Two weeks ago this defective valve in me tore, causing serious chest pains. I went to the ER and to make a long story short, they put a new, different valve in me. I believe that the hospital, surgeon, or cardiologist had to know about[Show More]I had one of these Trifecta GT valves put in me in July of 2020. I never felt well after that surgery and I told my cardiologist over and over again about this. Two weeks ago this defective valve in me tore, causing serious chest pains. I went to the ER and to make a long story short, they put a new, different valve in me. I believe that the hospital, surgeon, or cardiologist had to know about this faulty valve they put in me. I was never, ever contacted about this though. I was one of the lucky ones who didn't die from this, but I did have to spend 11 awful days in the hospital before and after getting the new valve last week. I am now recovering from a very, very unpleasant situation.