(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effect of hypotension as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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This is filed to report hypotension treated with medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Shortly after the steerable guide catheter (sgc) crossed the septum, the arterial pressure decreased.The patient was given chest compressions to stabilize the pressure.The pressure remains low, but stable.It was possible that the guide wire may have triggered a vasovagal reaction, but this was not confirmed.The procedure was aborted.No clips were implanted, and mr remains at 4.There was no clinically significant delay in the procedure.No additional information was provided.
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