It was reported through a research article that 298 patients underwent mitral transcatheter edge-to-edge repair (m-teer) from (b)(6) 2014 to (b)(6) 2022.Within two years of the procedure, the implanted mitraclip may have caused or contributed to recurrent mitral regurgitation, heart failure hospitalization (hfh), and patient death.Additional information is listed in the attached article, titled ¿prognostic value of right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair.¿.
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The devices were not returned for analysis and a review of the lot history record could not be performed as the part/lot information was not provided.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported heart failure/congestive heart failure, mitral valve insufficiency/regurgitation and death cannot be determined.However, mitral regurgitation, heart failure and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Literature attachment: article title: prognostic value of right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair.
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