Thoratec HeartMate II LVAD Lawyers:
Reviewing Potential Blood Clot Injury Lawsuits

Harvey Kirk

By Harvey Kirk
Posted December 2, 2013


The product liability lawyers at Saiontz & Kirk, P.A. are evaluating the potential legal claims on behalf of individuals nationwide who have suffered a blood clot injury after receiving the Thoratec HeartMate II Left Ventrical Assist Device (LVAD).

Also referred to as a Left Ventrical Assist System (LVAS), the HeartMate II is a mechanical heart pump that is used to continuously push blood through the heart. It is a critical treatment device for patients with advanced heart failure who are awaiting a heart transplant or too weak to undergo such a procedure.

According to a study published in New England Journal of Medicine, that rate of pump thrombosis, or blood clots with the HeartMate II has increased dramatically since early 2011.

While all mechanical heart implants are prone to blood clots that may form on the surface of the device, researchers indicate that the rate of HeartMate II problems increased from approximately 2.2% prior to March 2011, to 8.4% for devices implanted since then.

A Thoratec HeartMate II blood clot can develop on the blood-contacting surfaces of the heart pump, including the inflow cannula or outflow conduit. As a result of the thrombosis, patients may suffer:

  • Emergency Heart Transplant
  • Pump Replacement or Removal
  • Sudden Death

After noticing an increase in the number of patients experiencing blood clot problems after receiving a Thoratec HeartMate II LVAS, doctors at the Cleveland Clinic performed an analysis of data involving 837 patients treated between January 2003 and May 2013 at their hospital, as well as Washington University Barnes-Jewish Hospital and Duke University Medical Center. The findings noted a sudden increase in the rate of complications after March 2011.

Researchers also noted that the increase in blood clots from the HeartMate II was accompanied by an increase in levels of LDH, which may be an indicator for the formation of clots.

Following March 2011, the study found that blood clot rates not only increased, but were occurring much sooner after the artificial heart pump was implanted. While the median time between implant and blood clots that developed prior to March 2011 was 18.6 months, the median time was only 2.7 months after early 2011.

While Thoratec has not disclosed any recent changes to the design or functioning of the pump, the sudden increase in the HeartMate II pump thombosis risk appears to be supported by data from a federally funded registry known as Intermacs. Data from that registry also shows an increase from 2% during prior years, to 5% after May 2011. While the increase was less than researchers found at their hospitals, the registry may not capture all cases, such as those involving emergency heart transplants after a clot forms.

Based on these findings, the FDA has indicated that it is reviewing the matter and that the agency shares the concerns expressed by the researchers about the potential increased risk of HeartMate II blood clots that may develop shortly after implanted.

As the investigation is continuing, the HeartMate II blood clot lawyers at Saiontz & Kirk, P.A. are closely monitoring these problems and evaluating whether individuals who experienced an injury may be able to pursue financial compensation through a product liability lawsuits. To submit information about a potential HeartMate II lawsuit for review by our lawyers, request a free consultation and claim evaluation.

12 Comments • Add Your Comments

  • Tom says:

    My Heartmate i2 was installed on 29 June, 201`2.

    No known clot problems yet.

    But had a massive failure of base power unit April 23. Damned near died. Was comatose for several days and have made a “miraculous” recovery. They told my wife she could pull the plug, but she obviously declined. My neurologist, last week, said my middle name should be “Lazarus”.

    Posted on February 24, 2014 at 2:53 pm

  • Tonya says:

    My Husband died last year after one month from getting LVAD. He developed a clot. Doctors all seemed clueless about some of his earlier systoms. I feel this device took him from us. I’m on a mission to stop others from having to endure pain and suffering as a result of this monster device.

    Posted on August 18, 2014 at 10:03 am

  • Denisa says:

    I lost my husband last year to this lvad I won’t them to pay for not telling the truth he never had life after it was put in

    Posted on March 13, 2015 at 2:07 pm

  • June says:

    This is the worst thing that could happen to a family. My husband has lost quality of life. It will be 2 years in December. I would not recommend this surgery to anyone.

    Posted on July 20, 2015 at 12:02 pm

  • Diane says:

    My husband received his LVAD September 2012. Since then he has had many, many bleeding issues and a stroke. Now he’s developed a driveline infection. He’s been hospitalized numerous times and quality of life has been adversely affected. I would not recommend this device to anyone!

    Posted on September 26, 2015 at 9:18 pm

  • Betty says:

    My husband died last year in February. He had the LVAD pump put in on September 8,2012. I wouldn’t recommend this to anyone. It made our life a living hell. They don’t tell you the bad part about this pump. They tell you all the good things. They told me and my husband that he wouldn’t have to keep the pump for no more than a year. My husband had his pump for over three years. His driveline became infected maybe six months after the surgery. After that all hell broke loose. They had to take the driveline from the left side to the right. He had a deep cut out of his stomach, so he had to drag a wound vac around with the pump equipment for about three months. The pump had a bacteria in it. The bacteria spread all over his body. They had to cut a deep hole out of his side where they ran the driveline to the right side, because a hard core grew around the driveline due to the infection. For the last two years we stayed in the hospital more than we stayed home. He had a stroke. I could go on and on. They wouldn’t replace the pump. I asked several times if it’s in the pump then can you please change the pump. They told me all kind of lies. My husband looked like a skeleton before he died. He told me that they used him to experiment on. They didn’t do as they promised. I don’t think half the people need the LVAD anyway. It’s all about the money. I wouldn’t recommend this to anyone. When my husband had the stroke they sent him home with an IV pick line and had me giving him medicine through the IV line every eight hours. I’m now disabled and can’t work. The last stroke he had was in the front of the brain. This stroke happened in February 2015. He didn’t come back to me this time. We were really tricked. They need to take this crap off the market. It’s totally bull shit. It put me through hell. If I could just stop this from happening to other people I would. I’m only telling some of what happened. He was number 27. Can you imagine how many have been fooled since September 2012? I just hope no one ask me to speak about it, because this is one thing they really need to take off the market. They took my best friend away from me. I miss him so much.

    Posted on January 19, 2016 at 10:49 pm

  • Cathy says:

    My husband has suffered since Nov.2011.He also has had every complication possible including replacing the 1st LVAD in 2013 because it disconnected. He has never been the same. Alive but not! Hate this device and what it has done to our family.

    Posted on March 10, 2016 at 12:40 pm

  • Martha says:

    My husband received his heart mate 2 in June 2013. Since then he had several infections that required iv antibiotics and oral antibiotics. He had several strokes and blood clots. Also had to be on blood thinner daily because of hid INR. He went in for regular doctor appointment on April 5,2016 and passed away on April 8, 2016 three days ago. They claim he had a stroke and severe bleeding on the brain.

    Posted on April 11, 2016 at 11:04 am

  • Troy says:

    My brother age 45 had a Elvinta heart transplant put into his chest August 2015 since then he’s been very good shape up until the last week here they put him in hospice and while he was coherent before they put him there two days ago and now they’re keeping him very highly sedated when I know he was able to talk to me I think they’re trying to cover something up but they did something called oblations on the right ventricle of his heart practicing with non-FDA approved medications as I said my brother is 45 years old doesn’t deserve all the pain and suffering that I have watched him and door over the period of a year

    Posted on May 28, 2016 at 9:31 pm

  • Rhonda says:

    My father had a heart mate II heart pump LVAD installed two years ago due to a failing heart due to a congenital heart defect. This was to be a bridge to transplant. One month ago, he really started to decline in health. His pump has drastically reduced his blood flow dramatically to the point of having failing respiratory and kidney function. He was transported to Oklahoma City from Tulsa by ambulance. After spending about a week in the hospital there, they said they simply could not do anything for him but to send him to Houston, TX where he had the pump installed. He was so very weak. The hospital had actually wanted to release him to go home which was an hour and a half drive away. He told me on the phone when I called him for the last time that he was too weak to go home. He Never Wanted to stay in a hospital ever, but this time he knew his condition was serious if not fatal. Not only did the hospital want to release him to go home, they wanted him to make the 10 hr trip to Houston by car! At the last minute he took a turn for even worse. They could not keep the blood clots from forming at all after all sorts of heavy duty blood thinners. The decision was to life flight him from OKC to Houston. On the flight he was heavily sedated to the point of being nearly dead by the time he arrived in Houston after a 3 hr flight. Upon arriving at the St Luke’s Episcopal hospital he was immediately put on full life support. We were told they were simply trying to improve his condition by support to be able to exchange the heart pump for a new one. There was never any improvement over the week they kept him on support although we were told that the plans were to exchange the pump in a few days. On the day of the surgery, the procedure was suddenly canceled. We were told that he had uncontrollable blood pressure that could not be stabilized by medication and he had developed pneumonia. Also, there was not a lot of brain function. The suggestion was for me and my siblings to consider taking him off support. In the end that is what we did. I feel we were led astray from the beginning. Making us think all would be ok and he had a very good chance of survival. Even were told that he had good brain function too since he had tried to pull the tube out of this throat twice. We took him off support and he died 8 minutes later. This was on 10-7-16. I feel that had the pump been replaced when the recall was issued due to clotting, he would still be with us today. He was only 64 and healthy other than his failing heart. It is almost like many people were put on these pumps to be left to die. The odds of getting a matching donor heart is very slim anyway. I sure hope that something can be done to keep others from losing loved ones as I have recently.

    Posted on October 27, 2016 at 3:10 pm

  • Sarah says:

    My dad is on his second LVAD (heartmate 2) in 9 years. We consider every day with him a bonus day and have been blessed with many of those. I would hate to see lawsuits and litigation costs prevent the availability of this device to others. It is a high risk transplant with no guarantees and multiple complications but it is typically offered when the alternative is certain death. (my dad had CHF with 5% ef and less than 30 days to live) I have total sympathy for those that have lost a loved one and who’s journey with the LVAD was a difficult or unsuccessful one. We’ve had our fair share of life or death moments in the past 9 years but I’ve only ever encountered a caring and compassionate team with a mission to improve upon treatment and diagnosis and a mission to save my dad. I just wanted to share a positive lvad experience.

    Posted on May 30, 2017 at 1:08 pm

  • John says:

    I had my 1st lvad in March 2016 got an infection after leaving the hospital that went on until finally in November after 5 trips to the or to flush out the infection and months of wound vac and antibiotics in and out of the hospital they had to replace it then March 2017 at a clinic visit while changing from wall power to batteries it shut off I was admitted on a Friday had another replacement surgery now on February 27 of this year I was laying on my couch it alarmed and shut down again I went to er stayed for 4 days and came home then 2 weeks later I was woken to an alarm again saying call hospital driveline disconnect I’ve told them the controller was recalled thinking maybe that’s the problem and up until that visit I’ve had the recalled controler they changed it so hopefully that was the problem but these in my opinion are garbage I’m greatful to have had these past 2 years of life but we always worry if it happens again will it turn back on again ,someone has to be responsible for this every lawyer I contact says nothing they can do ,I hope someone can help me I’ve suffered more than I’ve ever with this thing

    Posted on February 17, 2018 at 11:44 am

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