Death and event dates: dates estimated.The udi number is not known as the part and lot number were not provided.The device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.Based on the information reviewed and due to the limited information available from the article, a cause for the reported death cannot be determined.However, death is listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Literature article title ¿biventricular physiology of iatrogenic atrial septal defects following transcatheter mitral valve edge-to-edge repair.¿.
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This is filed to report death.It was reported through a research article identifying steerable guide catheters that were related to the following outcomes: death.Specific patient information is documented as unknown.Details are listed in the attached article, titled, "biventricular physiology of iatrogenic atrial septal defects following transcatheter mitral valve edge-to-edge repair.¿ no additional information was provided.
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