The additional clip delivery system is filed under a separate medwatch report number.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information provided the endocarditis is the result of procedure conditions.The reported septic embolism is the result of the endocarditis.The reported fever and infection (meningitis) are the result of the septic embolism.The reported patient effects of fever, embolism, endocarditis, and infection (meningitis), as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is being filed to report the endocarditis.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.Two ntr clips were implanted, reducing mr to 1-2.On (b)(6) 2020, the patient was rehospitalized with fever and meningitis related to septic embolism.A transesophageal echocardiography (tee) was performed which showed vegetation on the mitral valve.The patient remains hospitalized and treated with medication.No additional information was provided.
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