EuroIntervention · 2019 · 37 citations · 4 references
MedicineCardiologyAssistive TechnologyInterventional CardiologyPatient SafetyMedical Device Adverse Event ReportingMedical Device Risk ManagementMedical Device SafetyPostmarket ReportingDevice-related Adverse Event AnalysisFailure ModesImpella DevicesLeft Ventricular Assist DevicesPost-marketing SurveillancePost-marketing Surveillance AnalysisPost-marketing Surveillance DataSerious Adverse Events
Robust data on the commonly reported complications and failure modes associated with Impella (Abiomed Inc, Danvers, MA) is limited. We analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess these
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Charanjit S. Rihal, Srihari S. Naidu, Michael M. Givertz et al. · Journal of the American College of Cardiology · 2015 · 671 citations
Medicine, Cardiology, Surgery +8
William W. O’Neill, Theodore Schreiber, David Wohns et al. · Journal of Interventional Cardiology · 2013 · 387 citations · Full text