Percutaneous management of RetroFlex 3 balloon rupture and separation of the Edwards Sapien delivery system

Tex Heart Inst J. 2014 Dec 1;41(6):641-4. doi: 10.14503/THIJ-13-3447. eCollection 2014 Dec.


We report the case of an 85-year-old woman with severe aortic stenosis who underwent transcatheter aortic valve replacement with use of the Edwards Sapien(®) valve system. The procedure was complicated by rupture of the valve-deployment balloon, with separation and retention of the nose cone of the RetroFlex 3(®) delivery system in the iliac artery. Our endovascular retrieval of the equipment was successful, and we achieved access-site hemostasis by deploying a covered stent. To our knowledge, this is the first report of the endovascular retrieval of a malfunctioning delivery system during transcatheter aortic valve replacement.

Keywords: Aged, 80 and over; cardiac catheterization/adverse effects; endovascular procedures/adverse effects/instrumentation; equipment failure; heart valve prosthesis implantation/adverse effects; iliac artery/injuries; treatment outcome.

Publication types

  • Case Reports
  • Video-Audio Media

MeSH terms

  • Aged, 80 and over
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / therapy*
  • Balloon Occlusion
  • Cardiac Catheterization / adverse effects*
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheters*
  • Device Removal
  • Female
  • Heart Valve Prolapse*
  • Heart Valve Prosthesis Implantation / adverse effects*
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control
  • Humans
  • Iliac Artery / diagnostic imaging
  • Iliac Artery / injuries
  • Prosthesis Failure
  • Radiography
  • Severity of Illness Index
  • Treatment Outcome
  • Vascular System Injuries / etiology
  • Vascular System Injuries / therapy