Vorkommnismeldungen bei mechanischen Herzklappenprothesen

BACKGROUND. The purpose of this studywas to collect the experience gained from risk assessment of incidentsassociated with mechanical heart valves as reported to the GermanMedical Devices Vigilance System. METHODS: All events in connection withthe use of prosthetic heart valves which had been reported to theFederal Institute for Drugs and Medical Products were identifiedin the Institute's anonymized database. Subsequently all informationthat had been obtained and the reports of investigations by thevarious responsible manufacturer of medical products were retrospectivelyanalysed. RESULTS. Of 53 incident reports theaortic valve position was involved 32 times, the mitral valve position21 times. 17 cases of leaflet breakage, 12 of leaflet dysfunction,6 of valve thrombosis, 4 of paravalvular leakage, 4 of damage tothe suture ring, 3 of endocarditis and 7 of various other singulardefects were reported. The outcome was mostly very serious (re-surgery,prolongation of surgery, death). Corrective actions taken by the manufacturersconsisted of recalls, advisory notices and stoppage of production. CONCLUSIONS. The Medical Devices VigilanceSystem is able to detect product failures of mechanical heart valvesand to initiate corrective action. As the reporting rate over morethan 10 years is relatively low, it can be assumed that in generalmechanical heart valves are safe medical devices. The quality ofincident reporting by manufactures and users of medical devicesshould be improved to reduce the number of undetected and unsolvedincidents.