3 results

• Sapien 3 TAVR Lawsuit Claims Valve Caused Iliac Artery Perforation, Wrongful Death

  July 22, 2026

  Michael Adams

  Lawsuit alleges defects involving an Edwards Lifesciences Sapien 3 Ultra heart valve and related delivery devices perforated a woman’s iliac artery and abdominal aorta during a TAVR procedure, resulting in catastrophic vascular injuries and death.

• Sapien 3 Transcatheter Heart Valve Recall Follows Reports Of Balloons Bursting During Implantation

  August 23, 2019

  Russell Maas

  A recall warns that Sapien 3 Transcatheter Heart Valve balloons may explode while being implanted, which has already resulted in 17 injuries and one patient death.

• Concerns Over Growing Use Of Artificial Heart Valves Among Younger Patients Raised in “Implant Files” Report

  December 4, 2018

  Irvin Jackson

  A new report warns that too little is known about the durability of transcatheter aortic valve replacement procedures, which are relatively new, and being used on younger and younger patients.