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.The investigation was unable to determine a cause for the reported unspecified tissue injury and thrombosis.Unspecified tissue injury and thrombosis are listed in the instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is filed to report thrombus and tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advancing towards the left atrium when a structure was observed near the sgc.The structure is suspected to be thrombus or possible tissue damage.The activated clotting time (act) was approximately 300 at this time.After a couple of minutes, the structure was no longer visible.The procedure continued and the same sgc was advanced to the mitral valve, and the clip was deployed.Three clips were implanted, reducing mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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