This is filed to report a cable break.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The mean pressure gradient was 2mmhg and a there was a restricted posterior leaflet.The steerable guide catheter (sgc) was inserted without issues.However, while removing the dilator, minus knob was taken off, but it was observed the sgc did not curve.A cable break was suspected, but the physician decided to continue with the procedure.After the clip delivery system (cds) was inserted, an aorta hugger was observed.The physician attempted to implant the clip, but after the leaflets were grasping, the gradient increased to 35mmhg.Due to the increase in gradient, the physician decided to remove the devices and discontinue the procedure.The gradient returned to 2mmhg.Mr remained at a grade of 3.The physician stated the increase in gradient was due to angle of the clip and patient anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, a cause for the reported cable break could not be determined.The reported inability to curve the device appears to be a cascading effect of the cable break.There is no indication of product issue with respect to manufacture, design or labeling.
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