Description of Event or Problem · 1
A MEDTRONIC ENDURANT ENDOGRAFT WAS USED IN AN EMERGENT SETTING TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PROCEDURE WAS CONDUCTED IN AN OPERATING ROOM USING PORTABLE FLUOROSCOPY EQUIPMENT. THE ENDOGRAFT HAD A PROXIMAL DIAMETER OF 28MM AND WAS PLACED IN AN AORTIC NECK MEASURING APPROXIMATELY 23MM. APTUS ENDOANCHORS WERE USED TO SEAL AN ACUTE TYPE I ENDOLEAK OBSERVED IMMEDIATELY FOLLOWING ENDOGRAFT PLACEMENT. FOUR (4) ENDOANCHORS WERE PLACED UNEVENTFULLY AND THE ENDOLEAK WAS CONFIRMED TO HAVE BEEN RESOLVED. FOLLOWING ENDOVASCULAR DEVICE REMOVAL, THE OPERATING PHYSICIAN ATTEMPTED TO PERFORM A PATCH ANGIOPLASTY ON THE RIGHT FEMORAL ARTERY, WHICH WAS USED FOR PRIMARY DEVICE ACCESS FOR BOTH THE ENDURANT GRAFT AND HELI-FX SYSTEM. DURING THE PATCH ANGIOPLASTY PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT CODED. SUSPECTING FURTHER RUPTURE, AN URGENT OPEN EXPLORATION WAS PERFORMED TO LOCATE THE SOURCE OF INTERNAL BLEEDING. NO BLEEDING WAS FOUND AT THE INITIAL ANEURYSM RUPTURE SITE OR AT THE LOCATION OF THE PROXIMAL ENDOGRAFT SEAL AND ENDOANCHORS. THE LOCATION OF THE BLEEDING WAS NOT IDENTIFIED. THE PATIENT EXPIRED ON THE OPERATING TABLE. THERE WAS NO APPARENT OR ALLEGED DEVICE MALFUNCTION WITH EITHER THE HELI-FX SYSTEM OR THE ENDOGRAFT, AND NO CAUSAL LINK ESTABLISHED BETWEEN THE USE OF THE DEVICES AND THE PATIENT'S DEATH.