During investigation, a review of complaint history, instructions for use (ifu) and trends was conducted.The zenith aaa endovascular device has completed design control requirements showing the device meets the predetermined requirements and that the requirements meet the needs of the user.Zenith products are shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.The event shall be trended as resulting in serious harm the patient, as it was reported that the renal artery was embolized.There is no evidence to suggest that the device was not manufactured to specification.Minimal information was provided to assist with this case and based on the available information, a definitive root cause cannot be determined or reported at this time.The appropriate internal personnel have been notified and will continue to monitor for similar complaints.
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