Client
LivaNova, plc is an Italian-American medical device manufacturer based in the UK. The company develops devices used for cardiac surgery and neuromodulation. The company was formed in 2015 by a $2.7B merger between Houston, Texas-based Cyberonics, Inc. and Milan, Italy-based Sorin S.p.a.
Challenges
LivaNova faced challenges complying with FDA 21 CFR Part 821 medical device tracking requirements. Due to incomplete records, they lacked contact information for hospitals where specific cardiac valves had been sent. This created a risk of regulatory penalties and hindered their ability to notify healthcare providers about the recall and subsequent patient notifications.
Solution
IRC conducted a detailed outreach campaign to identify and collect contact information for hospital staff responsible for tracking the affected devices. This included gathering names, titles, emails, phone numbers, and mailing addresses. A secondary phase involved contacting these individuals again to confirm receipt of notifications and acknowledgment of compliance via a provided link.
Results
IRC successfully identified and provided LivaNova with accurate and complete contact details for responsible parties at the hospitals. This enabled LivaNova to send notifications via email, mail, and phone, ensuring compliance with FDA regulations. LivaNova expressed satisfaction with the results and demonstrated confidence by indicating plans for future collaborations.
Business Benefits
Ensured regulatory compliance: Addressed LivaNova’s FDA compliance risk, avoiding potential legal and financial penalties.
Improved data accuracy: Delivered clean and complete contact details, resolving gaps caused by incomplete legacy records or merger-related data issues.
Facilitated recall process: Enabled hospitals to locate affected devices and inform patients efficiently.
Enhanced operational efficiency: Streamlined LivaNova’s recall communication by providing comprehensive contact databases.
Strengthened client trust: Positive feedback and willingness for future collaboration underscored the client’s satisfaction.
Mitigated risk exposure: Reduced the likelihood of compliance failures, protecting LivaNova’s reputation and standing with regulatory bodies.