inforMED
InjuryNQH

CARDIOMEMS ENDOSURE DELIVERY SYSTEM

Received Jun 18, 2007 · Event occurred Jun 7, 2007

Report 3004936110-2007-00007 · MDR key 874184

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Catalog number

ADS-1001

Product problems

  • Unknown (for use when the device problem is not known)

Patient

82 YR

  • Improved patient condition
  • Transfusion of blood products
  • Blood pressure, decreased
  • Blood Loss

Narrative

Description of Event or Problem

DURING THE CASE, THERE WAS SIGNIFICANT BLOOD LOSS AROUND THE SENSOR TETHER AND MAIN BODY OF THE STENT GRAFT (APPROXIMATELY 900CC). THIS MAY HAVE TRIGGERED A VAGAL RESPONSE AS THE BLOOD PRESSURE DROPPED FROM 130 TO 80. THE PATIENT RECEIVED 1.5 UNITS OF BLOOD AND FLUIDS ON THE TABLE. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.