This is filed to report cardiac arrest and medical intervention it was reported that this was a mitraclip procedure to treat mixed regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) crossed the septum; however, then the patient went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed, and after two hours, the patient was stabilized.The physician stated that the sgc did not cause the patient to experience cardiac arrest, but this cannot be confirmed.The procedure was aborted.No clips were implanted, and mr is 4.A re-do clip procedure will be scheduled at a later date.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 that would have contributed to the reported event.Based on the available information, a cause for the reported cardiac arrest could not be determined.Additionally, cardiac arrest is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The additional therapy/non-surgical treatment 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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