InjuryNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Nov 1, 2007 · Event occurred Oct 17, 2007
Report 3004936110-2007-00017 · MDR key 937404
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
65 YR
- Bleeding
- Transfusion of blood products
Narrative
Description of Event or Problem
THE SENSOR AND DELIVERY SYSTEM WERE PLACED THROUGH A CONDUIT AND INTO A THORACIC ANEURYSM (OFF-LABEL USE). THERE WAS BLEEDING DURING THE PLACEMENT OF THE SENSOR. A 20F SHEATH FOR THE ENDOGRAFT WAS THEN PLACED BESIDE THE SENSOR DELIVERY SYSTEM. THERE WAS ADD'L BLEEDING WHILE THE SENSOR WAS ON THE DELIVERY SYSTEM NEXT TO THIS 20F SHEATH. THE PATIENT REQUIRED A UNIT OF BLOOD.