MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Sep 14, 2007 · Event occurred Sep 5, 2007
Report 3004936110-2007-00014 · MDR key 933057
Device
Product problems
- Fluid/Blood Leak
- Difficult to Insert
Patient
82 YR
- Bleeding
- Transfusion of blood products
Narrative
Description of Event or Problem
THE PATIENT HAD VERY CALCIFIED AND TORTUOUS ILIAC'S. THE SENSOR AND MAIN BODY OF STENT GRAFT WERE PLACED IN THE PATIENT, BUT NOT DEPLOYED. WHILE THESE WERE IN PLACE A LEFT RENAL ARTERY STENT WAS PLACED FROM BRACHIAL ACCESS. THIS TURNED OUT TO BE A LENGTHY STEP IN THE PROCEDURE AND DURING THIS TIME, THERE WAS MUCH BLEEDING FROM THE VALVE OF THE SHEATH WITH THE SENSOR AND MAIN BODY OF THE STENT GRAFT. AFTER THE SENSOR AND MAIN BODY OF THE STENT GRAFT WERE DEPLOYED THE BLEEDING IMPROVED, BUT BLOOD HAD TO BE GIVEN TO THE PATIENT. THE CASE WAS COMPLETED WITHOUT ANY ISSUE.