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 the reported event.Based on available information, causes for the reported air embolism and hypotension could not be determined.Additionally, air embolism and hypotension are listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported medication required was 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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His will be filed to report during use of the steerable guide catheter, air was noted in the left ventricle.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 left atrium (la) with no issues.During removal of the dilator and guide wire, air was noted in the left ventricle and the patient's blood pressure dropped.Medication was administered.There was no additional treatment performed for the air embolism as it dissipated on its own.The procedure was completed by implanting one clip, reducing mr to <1.No additional information was provided.
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