Institute of Good Manufacturing Practices India®

Global accredited training & certification provider

IGMPI Approvals & Accreditation : Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India, Approved Training Institute of Food Safety and Standards Authority of India (FSSAI), Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh, Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC)
Trusted by organizations & training participants in over 30 countries. Training | Certification | Education | Research

Burst balloon risk warning with Sapien 3 Ultra heart valve


18th July 2019

Edwards Lifesciences has warned the doctors about the low risk of burst balloons during its Sapien 3 Ultra replacement heart valve’s implantation. Physicians are also cautioned to closely follow the instructions for use to avoid the problem.

The Irvine, California-based company won CE-Mark in the European Union in November 2018 for the latest iteration of its transcatheter aortic valve replacement. Its approval from the FDA followed in December.

The company said that they have received many reports of burst balloons with the Sapien 3 ultra and this had made the withdrawal of the system from the patient very difficult. The complaint rate is around 1.0% “based on the limited experience with the device” and about 0.5% of them have caused clinical implications for the patient including difficulty in removal of valve’s delivery system, vascular injury.

Two factors influencing balloon bursts, excess inflation volume and fast inflation conditions were observed in the investigation and these are addressed in the Sapien 3 Ultra instructions for use.

Additional warning will also be added to the device’s instructions for use, to avoid failures in slow inflation to prescribed volumes and balloon rupture.


For further enquiries, write to or call us on:
info@igmpiindia.org/ +91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280

Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like