Concerns have been raised that individuals who received a Thoratec HeartMate II heart pump since early 2011 may face a higher risk of blood clots than has previously been associated with the device. As a result, potential claims are being evaluated for those who have suffered a blood clot injury that may be linked to changes to the device, warnings or performance.
THORATEC HEARTMATE LAWSUIT STATUS: Following a study published in November 2013, product liability lawyers are reviewing whether individuals may be entitled to financial compensation through a Thoratec HeartMate II lawsuit if they suffered a pump thrombosis or blood clot during the months after the device was implanted, which may result in:
- Need for Emergency Heart Transplant
- Replacement or Removal of the HeartMate II
- Sudden Death
- Other Complications
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MANUFACTURER: Thoratec Corporation
OVERVIEW: The Thoratec HeartMate II Left Ventricular Assist System (HM II LVAS) is a blood pump that is implanted in people with a diseased or damaged heart to help pump blood throughout the body. The mechanical heart is a small device that is designed for children, women and small men.
The HeartMate II LVAS was first used in clinical trials beginning in November 2003. Thousands of patients have received the artificial heart, with annual sales reaching nearly $500 million per year by the third-quarter of 2013.
HEARTMATE II PUMP THROMBOSIS PROBLEMS: Reports suggest that in 2012, concerns began to surface among some doctors about an increase in the rate of pump thrombosis or blood clot problems that were developing among patients who received the Thoratec HeartMate II LVAS.
In November 2013, researchers from the Cleveland Clinic published a study in the New England Journal of Medicine, which evaluated data involving 837 patients treated at three different hospitals between January 2004 and May 2013. The pooled data demonstrated that for HeartMate II implants after March 2011, the rate of blood clots increased to 8.4%, from a prior pump thrombosis rate of 2.2%.
Out of 66 patients that experienced HeartMate II pump blood clots, 21 patients died soon after. Urgent heart transplants were needed in 11 cases, pump replacement was needed in 21 cases, pump removal in 2 cases and medical management in 38 cases.
Along with the overall increase in clots, researchers also found that the pump thombosis typically occurred much sooner after March 2011, with the median amount of time between implant and the clots dropping from 18.6 months during prior years to only 2.7 months in recent years.
Researchers saw a similar rise in elevated levels of lactate dehydrogenase (LDH) among patients, which can serve as an indicator of hemolysis caused by clot formation in the HeartMate II pump.
Some experts have suggested that changes to the design of the heart pump or software systems may have caused or contributed to these problems.
In August 2015, the FDA issued a warning that the HeartMate II was linked to reports of strokes, bleeding events and pump thrombosis.
HEART MATE 2 RECALLS: The 2013 study comes following a history of problems with the HeartMate II, including at least two recalls that either resulted in severe injuries or deaths to patients.
An Urgent Device Correction Notice was issued for HeartMate II LVAS pumps with catalogue numbers 1355 to 102139 on October 24, 2008. The percutaneous lead that connects the blood pump with the System Controller has been found to wear or fatigue over time, potentially leading to an interruption of pump function. This could result in the need for surgery to replace the artificial heart or cause potentially fatal injury.
Thoratec has received reports of 27 individuals who had their percutaneous lead wear or fatigue, requiring pump replacement. Five of these cases resulted in death.
According to estimates, the risk of lead damage increases the longer the blood pump is in place:
– 1.3% fail at 12 months
– 6.5% fail at 24 months
– 11.4% fail at 36 months
Doctors and hospitals were notified about the risk of HeartMate blood pump problems with the lead, and were advised to immediately replace the artificial heart if lead damage is confirmed.
In 2012, the company sent out a corrective notification warning of a outflow graft that could become disconnected, leading to blood loss and death. The FDA declared the action to be a class I recall of all HeartMate II models. There were 29 incidents reportedly linked to the problem, including one patient death which may or may not have been caused by the defective artificial hearts.
About 29,000 HeartMate II LVAS pocket controllers recalled in May 2017 following the deaths of 26 patients who attempted to change their controllers.
10 Comments
AngeliqueSeptember 22, 2020 at 1:02 am
My mother received the LVAD in Nov 2008. I think she was a guinea pig because to my understanding it was a new machine. After the implant, she was in ICU. They said that the surgery was successful. I don't ever remember her talking to me again.
DianeJanuary 22, 2020 at 5:41 am
I'm back on here (original post 2/17/2018) because I see there are more recent posts. Basically, I'm so disgusted with all these sights promising they will take cases involving LVADs, but after pursuing this for a number of years I've never been successful in finding ANYONE willing to even look into this. Based on the posts I see, it's obvious that problems continue to arise with the Heartmate I[Show More]I'm back on here (original post 2/17/2018) because I see there are more recent posts. Basically, I'm so disgusted with all these sights promising they will take cases involving LVADs, but after pursuing this for a number of years I've never been successful in finding ANYONE willing to even look into this. Based on the posts I see, it's obvious that problems continue to arise with the Heartmate II. WHY CAN'T SOMETHING BE DONE???
PattiAugust 24, 2019 at 6:22 pm
My husband had 4 LVADS in a 3 year period due to thrombosis and sadly I lost him in Feb 2017. I have reached out to Law Firms across the country in an attempt for awareness, but no one would listen. I am beyond frustrated!
BonnieJuly 18, 2019 at 10:26 pm
Well my husband had a Heart Mate II also. It had been re-wired once for wear as Thoratec called it??!! Well I finally came home one day to find him DEAD on the floor. From what I saw his equipment shorted out again . Well after two years of dealing with different lawyers no one could help me with getting justice for my loving husband at all. I totally believe Thoratec needs to be held responsi[Show More]Well my husband had a Heart Mate II also. It had been re-wired once for wear as Thoratec called it??!! Well I finally came home one day to find him DEAD on the floor. From what I saw his equipment shorted out again . Well after two years of dealing with different lawyers no one could help me with getting justice for my loving husband at all. I totally believe Thoratec needs to be held responsible for this defective equipment but no one seems to care!!!!! They will continue implanting this defective equipment and NO does anything!!!!
JohnSeptember 14, 2018 at 8:27 am
I’m on here again to see if there’s any help for me as I said before I originally had my first heartmate 2 it in March of 2016 then replaced due to infection in November of 2016 ,again in March 2017 I had surgery to replace it again due to malfunction now I had to go through surgery again to have it removed in February of 2018 due to several pump stops and driveline disconnects ,I had to go throug[Show More]I’m on here again to see if there’s any help for me as I said before I originally had my first heartmate 2 it in March of 2016 then replaced due to infection in November of 2016 ,again in March 2017 I had surgery to replace it again due to malfunction now I had to go through surgery again to have it removed in February of 2018 due to several pump stops and driveline disconnects ,I had to go through having my chest opened again ,12 hours of surgery and months of recovery I now have a heartware , needless to say I feel like the company who made heartmate 2 is responsible and should be held accountable after this last time if anyone can help me please do I would greatly appreciate it thank you
DianeFebruary 28, 2018 at 3:15 am
My husband received his Heartmate in September 2012. Less than a year later he suffered a stroke. He had severe gastro bleeding continuously causing weekly transfusions. In September of 2015 he got a driveline infection which turned into sepsis. He died in October 2015. I believe the Heartmate was responsible for his poor quality of life and death. I have also contacted a number of attorneys with [Show More]My husband received his Heartmate in September 2012. Less than a year later he suffered a stroke. He had severe gastro bleeding continuously causing weekly transfusions. In September of 2015 he got a driveline infection which turned into sepsis. He died in October 2015. I believe the Heartmate was responsible for his poor quality of life and death. I have also contacted a number of attorneys with no satisfaction. The Heartmate Ii is seriously flawed and the manufacturer needs to be held accountable.
JessicaJune 1, 2017 at 9:34 pm
My husband had a heart mate two 4/21/2016. Eight moths later had a clot in the pump that need immediate attention. He was admitted in the hospital and was put on top of the heart transplant list. Replacing the pump was not an option because it had moved. He was call for a heart transplant and did not make it because the pump had attached it self to the left lung lobe. This created severe bleedi[Show More]My husband had a heart mate two 4/21/2016. Eight moths later had a clot in the pump that need immediate attention. He was admitted in the hospital and was put on top of the heart transplant list. Replacing the pump was not an option because it had moved. He was call for a heart transplant and did not make it because the pump had attached it self to the left lung lobe. This created severe bleeding and because of this he lock oxygen in his brain. He passed 16 days after.
JohnApril 28, 2017 at 2:46 pm
I had to have surgery to replace my heartmate 2 I'm March, previously I had surgery to replace it due to infection in November,then in March I was at an appointment when my pump stopped running causing me to almost pass out, the Drs said there was a short in the driveline,after only 4 months I had to go through surgery again ,obviously there was and is a problem with this device,I could've died i[Show More]I had to have surgery to replace my heartmate 2 I'm March, previously I had surgery to replace it due to infection in November,then in March I was at an appointment when my pump stopped running causing me to almost pass out, the Drs said there was a short in the driveline,after only 4 months I had to go through surgery again ,obviously there was and is a problem with this device,I could've died if I had been at home when this happened ive tried to contact a number of attorneys ,there has to be something that can be done about this , clearly I'm not at fault .
DebraNovember 20, 2009 at 2:23 am
My husband passed away July 28th,2008, he had a HeartMate II put in , then his new heart come in and his heart was replaced,Tell what will the lead do to you from this device, The reason I ask is that The heart cordinator after my husband passed, resigned from his job and told me that things were not done right with My husband, and the death certificate says two differant things, And I can get any[Show More]My husband passed away July 28th,2008, he had a HeartMate II put in , then his new heart come in and his heart was replaced,Tell what will the lead do to you from this device, The reason I ask is that The heart cordinator after my husband passed, resigned from his job and told me that things were not done right with My husband, and the death certificate says two differant things, And I can get anyone to tell me for sure what he died of
Thoratec HeartMate II Blood Pump Warning: Lead May Fail : AboutLawsuits.comOctober 27, 2008 at 5:15 pm
[...] Corporation has warned that their HeartMate II blood pump may fail due to a defective lead that connects the heart pump with the System Controller. The lead [...]