This is filed to report an air embolism.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The left atrium was dilated and a prolapsed anterior leaflet.The mitraclip delivery system (cds) was advanced, negative was applied to try to get more lateral and posterior but the transseptal puncture was too low; the cds did not reach the valve.The devices were removed and a higher transseptal puncture was performed.The steerable guide catheter (sgc) was advanced, and the hemostatic valve failed; air entered the anatomy requiring additional aspiration and the sgc was removed from the stabilizer and placed down to resolve the air in the anatomy.No visible damage was observed to the hemostatic valve.A new sgc was used without further issues.A total of 2 clips were implanted.The mr was reduced to grade 3.There was 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on available information, a cause for the reported leak could not be determined.The reported air embolism appears to be due to the reported leak.Additionally, air embolism is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention is the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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