899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure
Kurosh Parsi, Lois Zhang, Mark S Whiteley, Selene Vuong, Mina Kang, Nikita Naidu, Joseph Gracé, David Connor
Abstract
Objective The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. Methods The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data. Results The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death. Conclusion CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.