This is filed to report the single leaflet device attachment (slda).It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, heart failure, re-hospitalization, medical intervention, and surgical intervention.Device issues include, single leaflet device attachment (slda) and inability to grasp.Details are listed in the attached article, titled ¿prognostic value of pre-operative atrial fibrillation in patients with secondary mitral regurgitation undergoing mitraclip implantation.¿ please see article for additional information.
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The devices were not returned for analysis.A review of the lot history records could not be performed due to unknown lot information.Additionally, a review of the complaint histories could not be performed due to unknown lot information.Based on the information reviewed, the cause for the reported single leaflet device attachments/slda and positioning failures / issues - leaflet grasping could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.
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