Expert review of medical devices · 2025
A retrospective study of reported adverse events associated with cardiac stents in Indian population.
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Mewada Sandeep, Shukla Shatrunajay, Soni Maneesh, Dahiya Meenakshi, Kalaiselvan Vivekanandan, Reddy Pooja, Mandloi Avinash Singh, Dhote Vipin
Аннотация
BACKGROUND: Cardiac stents are utilized to treat coronary artery diseases, a leading cause of death worldwide including in India. We investigated frequency and nature of adverse events (AEs) associated with cardiac stents in the Indian population.
METHODS: The source data was systematically collected by National Coordination Centre-Materiovigilance programme of India (NCC-MvPI), anonymized from 2020 to 2022. The database contained 10,542 reports of medical devices adverse events, with cardiac stents accounting for 2,075 of these events. These reports were meticulously collected, cleaned, segregated, and analyzed.
RESULTS: We observed that 93% AEs associated with cardiac stents were serious, with the most common being dissection followed by chest pain, thrombosis, and breathing difficulties. However, only 5% of reports resulted in death. Additionally, male patients experienced more AEs than female and elderly patients had a higher incidence of AEs after stent placement.
CONCLUSION: The study highlights the need for continued research in this area to identify the root cause of AEs associated with cardiac stents and develop effective measures to reduce these incidences. Future studies can also focus on evaluating the long-term outcomes of patients with cardiac stents to gauge safety and effectiveness of different stent types.
METHODS: The source data was systematically collected by National Coordination Centre-Materiovigilance programme of India (NCC-MvPI), anonymized from 2020 to 2022. The database contained 10,542 reports of medical devices adverse events, with cardiac stents accounting for 2,075 of these events. These reports were meticulously collected, cleaned, segregated, and analyzed.
RESULTS: We observed that 93% AEs associated with cardiac stents were serious, with the most common being dissection followed by chest pain, thrombosis, and breathing difficulties. However, only 5% of reports resulted in death. Additionally, male patients experienced more AEs than female and elderly patients had a higher incidence of AEs after stent placement.
CONCLUSION: The study highlights the need for continued research in this area to identify the root cause of AEs associated with cardiac stents and develop effective measures to reduce these incidences. Future studies can also focus on evaluating the long-term outcomes of patients with cardiac stents to gauge safety and effectiveness of different stent types.