CARDIOMEMS ENDOSURE SENSOR
Received Sep 19, 2008 · Event occurred Sep 3, 2008
Report 3004936110-2008-00006 · MDR key 1164104
Device
Generic name
Implantable Intra-aneurysm Pressure Measurement System
Manufacturer
Cardiomems, Inc.Catalog number
S2-2080
Product problems
- Device, or device fragments remain in patient
Patient
84 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE PHYSICIAN INADVERTENTLY DELIVERED THE SENSOR ABOVE THE DEPLOYED MAIN BODY OF THE STENT GRAFT. MULTIPLE ATTEMPTS WERE UNSUCCESSFULLY MADE TO BRING THE SENSOR BACK DOWN THROUGH THE MAIN BODY OF THE STENT GRAFT INTO THE ANEURYSM SAC. THE PHYSICIAN DECIDED TO RELEASE THE SENSOR IN THE AORTA ABOVE THE ANEURYSM/STENT GRAFT AND SNARE IT WHEN THE PLACEMENT OF THE STENT GRAFT WAS COMPLETE. THE STENT GRAFT WAS PLACED WITHOUT ISSUES AND AN ATTEMPT WAS MADE TO SNARE THE SENSOR. DURING THE ATTEMPT, THE SENSOR WAS NOT CAPTURED AND WAS INADVERTENTLY MOVED TO THE LOWER THORACIC AORTA. ADDITIONAL ATTEMPTS TO SNARE THE SENSOR WERE MADE. IT WAS DECIDED BY THE PHYSICIAN TO LEAVE THE SENSOR IN THE LOWER THORACIC AORTA. THE PHYSICIANS WILL FOLLOW THE LOCATION OF THE SENSOR ON X-RAY.