A heli-fx endoanchoring system was implanted prophylactically in a valiant stent graft system.The patient was noted to have a short aortic neck.It was reported during the index procedure, the heli-fx guide would not deflect and resistance was encountered when the applier was inside the guide catheter resulting in the endoanchors not being released.The device was replaced with another guide and the surgery completed successfully.Per the physician the cause of the event is product related.No additional clinical sequelae were reported and the patient is fine.
|