This is filed to report atrial perforation, tissue damage, difficult to remove.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the mitral valve, and the first clip was deployed, reducing mr.Then a second clip delivery system (cds) was advanced to the mitral valve; however, the septum tore causing the sgc to lose height.Then the cds dropped below the valve, and the clip became entangled with the chordae.After maneuvering, the clip became freed, but a chordal rupture occurred.A decision was made to remove the sgc and cds from the patient to abort the procedure.After the cds was removed, it was noted that the actuator mandrel was protruding distally.Additional treatment was not performed.The patient is stable.One clip was implanted, reducing mr to 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.Additionally, a review of the complaint history identified no other complaint reported from this lot.All available information was investigated and the reported physical resistance appears to be due to procedural circumstances/operational context and a conclusive cause for atrial perforation and difficult to remove could not be determined.The reported patient effect of atrial perforation (cardiac perforation) as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.
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