MalfunctionNQH
ENCLOSURE SENSOR
Received Mar 30, 2007 · Event occurred Mar 14, 2007
Report MW1042461 · MDR key 835156
Device
Product problems
- Difficult or Delayed Positioning
- Loose
- Device, or device fragments remain in patient
- Difficult to Remove
Patient
83 YR
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
DURING A ROUTINE ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR ON 03/14/07 AT THE TIME OF DEPLOYMENT OF THE CARDIOMEM PRESSURE SENSOR, THE SENSOR CAME LOOSE AND DEPLOYED WITHIN THE EXCLUDED ANEURYSM SAC. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE SENSOR WITHOUT SUCCESS. LENGTH OF TIP LEFT IN PT WAS APPROXIMATELY 2 - 2.5 INCHES. PATIENT WILL BE FOLLOWED CLOSELY BY MD.