MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Jul 9, 2007 · Event occurred Jun 22, 2007
Report 3004936110-2007-00008 · MDR key 2971423
Device
Product problems
- Difficult to Remove
- Separation Failure
Patient
67 YR
- Vessel Or Plaque, Device Embedded In
Narrative
Description of Event or Problem
THE SENSOR WAS PLACED IN THE AAA AFTER THE MAIN BODY OF THE STENT GRAFT WAS DEPLOYED. THE SENSOR WOULD NOT RELEASE EASILY FROM THE DELIVERY SYSTEM AND WAS PULLED DOWN LOWER THAN THE OPTIMAL POSITION ABOVE THE STENT GRAFT CONTRALATERAL LIMB GATE. AS THE CONTRALATERAL LIMB WAS INSERTED THE SENSOR WAS PUSHED INSIDE OF THE MAIN BODY OF THE STENT GRAFT. THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR AT THIS POINT AND AN ADDITIONAL AORTIC CUFF HAD TO BE PLACED INSIDE THE MAIN BODY OF THE STENT GRAFT TO TRAP THE SENSOR.