inforMED
MalfunctionNQH

CARDIOMEMS ENDOSURE DELIVERY SYSTEM

Received Sep 14, 2007 · Event occurred Sep 5, 2007

Report 3004936110-2007-00014 · MDR key 933057

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Catalog number

S2-2080

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.