CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Apr 20, 2007 · Event occurred Apr 9, 2007
Report 3004936110-2007-00005 · MDR key 847138
Device
Generic name
Intravascular Pressure Sensor
Manufacturer
Cardiomems, Inc.Model number
*Catalog number
ADS-1001
Lot number
*
Product problems
- Bent
- Kinked
- Use of Device Problem
Patient
77 YR
- Foreign body, removal of
Narrative
Description of Event or Problem
THIS WAS A PERCUTANEOUS CASE TO TREAT TWO ABDOMINAL AORTIC ANEURYSMS THAT WERE IN AN HOUR GLASS FORMATION. THE PLAN WAS TO PLACE THE SENSOR IN THE LOWER ANEURYSM JUST ABOVE THE BIFURCATION. AFTER ACCESS WAS GAINED, A HEAVILY CALCIFIED ILIAC, WHICH WAS NOT VISIBLE UNDER FLUOROSCOPY, CAUSED DIFFICULT ACCESS AND BENT THE PROTECTIVE CAPSULE SECTION OF THE DELIVERY SYSTEM. THIS BEND CAUSED THE TETHER TO KINK WHILE ATTEMPTING TO ADVANCE FORWARD. THE SENSOR DID ADVANCE UP TO THE LOWER ANEURYSM SAC. UPON REMOVAL OF THE DELIVERY SYSTEM, THE BEND IN THE DELIVERY SYSTEM CAPSULE CAUSED THE SENSOR AND TETHER TO BE PULLED BACK INTO THE ILIAC AND THEN FEMORAL ARTERY. THE PHYSICIAN THEN ATTEMPTED TO PULL THE SENSOR OUT THROUGH THE PERCUTANEOUS ACCESS SIGHT AND ACCIDENTALLY RELEASED THE SENSOR IN THE FEMORAL ARTERY. A CUTDOWN WAS PERFORMED AND THE SENSOR WAS RETRIEVED.