inforMED
OtherNQH

CARDIOMEMS ENDOSURE DELIVERY SYSTEM

Received Oct 5, 2007 · Event occurred Sep 20, 2007

Report 3004936110-2007-00016 · MDR key 929972

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Catalog number

S2-2080

Product problems

  • Component Falling
  • Device, removal of (non-implant)

Patient

75 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE SENSOR WAS PLACED WITHOUT ANY ISSUE. WHEN THE SENSOR WAS RELEASED FROM THE DELIVERY SYSTEM IF FELL DOWN INTO THE ILIAC ARTERY ANEURYSM. THE SENSOR WAS PLACED BACK INTO THE AORTIC ANEURYSM SAC, BUT EACH TIME IT FELL DOWN TO THE ILIAC. AFTER SOME TIME, THE SENSOR WAS REMOVED FROM THE PT WITHOUT ISSUE.