This is filed to report the patient deaths.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, stroke, ischemia, pericardial effusion, heart failure, bleeding, medical intervention, mitral valve replacement, and hospitalization.Device issues include, single leaflet device attachment (slda), and inability to grasp the leaflets.Details are listed in the article, titled ¿mitraclip therapy in daily clinical practice: initial results from the german transcatheter mitral valve interventions (trami) registry.¿.
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The devices were not returned for analysis.A review of the lot history records and the similar complaint review could not be performed, as the part and lot information regarding the complaint devices were not provided.The reported patient effect death, is listed in the mitraclip system instructions for use, as a known possible complications associated with mitraclip procedures.A cause for the death, cannot be determined.There is no indication, of a product issue with respect to manufacture, design or labeling.
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