CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Feb 2, 2007 · Event occurred Jan 22, 2007
Report 3004936110-2007-00001 · MDR key 813009
Device
Generic name
Intravascular Pressure Sensor
Manufacturer
Cardiomems, Inc.Model number
*Catalog number
ADS-1001
Lot number
*
Product problems
- Premature Activation
Patient
64 YR
- Surgical procedure, additional
Narrative
Description of Event or Problem
PATIENT HAD A LARGE ANEURYSM NECK AND TORTUOUS ARTERIES AND PHYSICIAN HAD DIFFICULTY IN IMPLANTING THE STENT GRAFT. THE SENSOR WAS DEPLOYED. WHEN THE SENSOR DELIVERY SYSTEM WAS WITHDRAWN, THE DILATOR/HYPOTUBE CAUGHT ON THE STENT GRAFT. THE PHYSICIAN REMOVED THE SENSOR DELIVERY SYSTEM, HOWEVER, THE MAIN BODY OF THE STENT GRAFT DEPLOYED PREMATURELY NECESSITATING ADDITIONAL STENT GRAFT COMPONENTS TO COMPLETE THE PROCEDURE. THE PATIENT WAS CONVERTED TO AN AUI WITH FEMORAL-FEMORAL BYPASS. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INCIDENT.