CARDIOMEMS ENDOSURE DELIVERY SYSTEM

Description of Event or Problem

A STANDARD AAA PROCEDURE WITH CARDIOMEMS ENDOSURE SENSOR WAS PERFORMED IN 2007. NOTHING UNUSUAL WAS REPORTED DURING THE CASE RELATED TO THE SENSOR DELIVERY. THE NEXT MONTH, THE PT RETURNED FOR A 30 DAY FOLLOW UP ABDOMINAL X-RAY. IT WAS NOTED THAT THE AAA WAS STABLE AND THAT THERE WAS TAPERED OBJECT RESEMBLING THE SHAPE OF A DELIVERY SYSTEM NOSECONE INSIDE THE STENT GRAFT AT THE LEVEL OF THE CELIAC ARTERY. TWENTY-SEVEN DAYS LATER, THE PT WAS ADMITTED TO THE ER FOR BACK PAIN. IT WAS DETERMINED THAT THERE WAS BLOOD IN THE AAA SAC. THE FAMILY ASKED THAT NO ADDITIONAL SURGERY BE PERFORMED. THE PT EXPIRED THE NEXT DAY. AN AUTOPSY WAS PERFORMED AND IT WAS DETERMINED THAT THERE WAS A ROUGH BONE SPUR PROTRUDING ANTERIORLY FROM THE L4 VERTEBRAL BODY THAT LINED UP WITH THE HOLE IN THE AORTIC SAC. THE AUTOPSY ALSO CONFIRMED THAT THE OBJECT INSIDE THE STENT GRAFT WAS THE DELIVERY SYSTEM NOSECONE BUT THAT THERE WAS NO PENETRATION OF THE STENT GRAFT BY THE DELIVERY SYSTEM TIP.