Description of Event or Problem · 1
MEDTRONIC VASCULAR BECAME AWARE OF A PATIENT ADVERSE OUTCOME FROM A PHYSICIAN PRESENTATION ON ENDOANCHORING RESULTS IN THE (B)(6). THE PHYSICIAN PRESENTER WAS NOT THE OPERATING PHYSICIAN FOR THE PROCEDURE BEING REPORTED. PER THE PRESENTATION, A PATIENT WHO WAS TREATED WITH HELI-FX ENDOANCHORS EXPERIENCED A PERFORATED AND ISCHEMIC BOWEL AND AN OCCLUDED ENDOGRAFT, AND EXPIRED. THE ENDOANCHORING PROCEDURE AND EVENT DATES ARE UNKNOWN AND IT IS NOT KNOWN IF THE PATIENT ADVERSE EVENTS AND OUTCOME WERE A RESULT OF THE ENDOANCHORS OR ENDOANCHORING PROCEDURE. IT IS ALSO UNKNOWN WHEN THE PATIENT ADVERSE EVENTS OCCURRED RELATIVE TO THE ENDOANCHORING PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN WERE UNSUCCESSFUL. THEREFORE, THE RELATEDNESS OF THE ENDOANCHORING PROCEDURE TO THE PATIENT'S COMPLICATIONS AND ULTIMATE DEATH CANNOT BE POSITIVELY CONFIRMED OR REFUTED.