A defective MitraClip Delivery System failed to release during a percutaneous mitral valve repair, necessitating emergency surgery that ultimately resulted in the patient's death from septic shock.
Case Report (n=1)
A case of fatal MitraClip delivery system failure highlights potential vulnerabilities in the European CE mark medical device regulatory process.
The use of medical devices is constantly growing and constitutes a valid aid to ailing people because of remarkable technological advances. The regulations on their circulation in Italy and Europe are inspired by the principle of free circulation: it is sufficient for a device to have the CE logo for it to be freely commercialized in all European countries. These regulations that favors commerce also expose the sick to the risk of harm from defective devices that have not been suitably checked prior to commercial release. This paper reports a case of a defective MitraClip© Delivery System, discusses other episodes of similar device malfunctioning, and analyzes the European legislation on medical devices. In the author's opinion, a careful 'control' policy for devices, an adequate care in device manufacturing, an appropriate evaluation of pre- and post-marketing and suitable measures for the patient's safety are needed.
Giordano et al. (Tue,) führten einen Fallbericht über dilatative Kardiomyopathie mit schwerer Mitralklappeninsuffizienz (n=1) durch. Das MitraClip-Abgabesystem wurde auf Geräteausfälle und das Überleben der Patienten bewertet. Ein defektes MitraClip-Abgabesystem konnte während einer perkutanen Mitralklappenreparatur nicht freigegeben werden, was eine Notoperation erforderlich machte, die letztendlich zum Tod des Patienten durch septischen Schock führte.