The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Based on available information, the reported damaged femoral artery appears to be due to challenging patient anatomy.The reported hemorrhage and hematoma appear to be cascading events of the damaged femoral artery.Additionally, hematoma, hemorrhage, and perforation are listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported surgery and hospitalization were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is filed for perforation of vessels, hospitalization, and surgical intervention.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022, to treat functional mitral regurgitation (mr) with a grade of 4.The anterior and posterior leaflets were restricted.One clip was implanted reducing the mr grade from 4 to 1.The steerable guide catheter (sgc) was straightened with the "-" knob and removed from the femoral vein.During groin management it was found that the femoral artery was damaged and this was confirmed with angiography.In the physicians opinion the damage occurred during femoral vein access due to patient anatomy.The groin was surgically closed.There was no clinically significant delay in the procedure.The patient was discharged on (b)(6) 2022.The patient was hospitalized again on (b)(6) 2022 for groin swelling due to a hematoma.No additional information was provided.
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