This is filed for access site bleed and respiratory distress.It was reported that on (b)(6) 2018, the patient, with functional mitral regurgitation (mr) of grade 4+, underwent a mitraclip procedure.Two clips were implanted and the mr was reduced to grade 2+.Post procedure, bleeding was noted from the access site.The hemoglobin level dropped; however, transfusion was refused by the patient.Due to the hemoglobin drop, respiratory insufficiency occurred and oxygen was administered.Medication was administered to stabilize the circulation and the patient remained in intensive care for three days.The adverse event resolved on (b)(6) 2018.No additional information was provided.
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(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of hemorrhage, respiratory distress and test result (hemoglobin level dropped), as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the patient effect of hemoglobin level drop (test result) resulting in respiratory insufficiency appears to be related to the hemorrhage from the access site.The hemorrhage was a result of procedural conditions as the steerable guide catheter (sgc) is inserted and removed through the groin access site in order to gain access to the femoral.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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