Call Today for a FREE Confidential Case Review
Toll-Free 24/7 (866) 920-0753

FDA: Bioprosthetic Heart Valves Linked to Blood Clot Risk

October 7, 2015 — The FDA has issued a Safety Communication about a possible risk of blood clots restricting movement of bioprosthetic aortic heart valves.

Concerns emerged after Dr. Raj Makkar of Cedars-Sinai Heart Institute in Los Angeles published a study in the New England Journal of Medicine.

Dr. Makkar found that 40% (22/44) of patients with a bioprosthetic aortic heart valve made by St. Jude Medical had impaired leaflet motion, possible due to blood clots. After looking at a registry involving 132 patients with devices made by other manufacturers, 17 (13%) had the problem.

Overall, six patients had a stroke or transient ischemic attack (also known as “mini-stroke”). The risk of stroke was higher for patients who were having problems with their heart valves, but the study was too small to draw any conclusions.

Bioprosthetic heart valves are made from cow, pig, or human tissue and are implanted in the aortic valve, which controls blood-flow from the main pumping chamber of the heart (left ventricle) and the rest of the body.

The valves are designed with three leaflets that keep blood moving in one direction. The problem is that blood clots may be preventing the valves from opening fully, which could potentially cause stenosis or strokes. However, more studies are needed to investigate the risk.

Do I have a Medical Device Lawsuit?

The Schmidt Firm, PLLC is currently accepting cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.