This is filed to report the perforation.It was reported this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr) with a grade of 4+.During advancement of the steerable guide catheter (sgc) just a few centimeters into the femoral vein, resistance was felt with the stenotic vessel and a vein perforation was noted.The sgc was removed without issue.A vascular surgeon was called, and balloon tamponade was performed, followed by stent implantation, resolving the perforation.The mitraclip procedure was aborted.No clips were implanted, mr remained 4+.Per the physician, it cannot be said for certain which device caused the injury to the vein.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of perforation as listed in the instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported failure to advance-septum appears to be due to challenging patient anatomy (stenotic vessel).The cause for the reported patient effect of perforation could not be determined.The additional therapy non-surgical treatment was a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Patient code 2226 - removed.
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