Dates estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information provided, a cause for the reported death, myocardial infarction, thrombosis, embolism and heart failure could not be determined.The reported patient effects of death, myocardial infarction, thrombosis, embolism and heart failure are listed in the mitraclip system instructions for use, and are known possible complications associated with mitraclip procedures.The reported hospitalization and additional therapy/non-surgical treatment were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article attached: dangerous liaison: successful percutaneous edge-to-edge mitral valve repair in patients with end-stage systolic heart failure can cause left ventricular thrombus formation.Na.
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This is filed to report death, myocardial infarction, thrombosis, embolism, heart failure, hospitalization and intervention.It was reported in a research article that the patient had functional mitral regurgitation (fmr) with a grade of 4+.A mitraclip was implanted, reducing mr to 1+.Follow up echocardiogram 2 days after the procedure showed left ventricular (lv) thrombus formation.Therapeutic heparinisation was started and the patient experienced a lateral wall myocardial infarction the following day.Coronary angiography revealed a thromboembolic occlusion of the left circumflex coronary artery which was successfully treated with balloon angioplasty.The patient recovered and was referred to a secondary hospital for further rehabilitation.The patient expired 2.5 months after the procedure due to lv failure.Additional details can be found in the attached article "dangerous liaison: successful percutaneous edge-to-edge mitral valve repair in patients with end-stage systolic heart failure can cause left ventricular thrombus formation".
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