CELSIOR
Received Aug 8, 2005 · Event occurred May 17, 2004
Report 2950168-2005-00002 · MDR key 625465
Device
Generic name
Organ Preservation Solution
Manufacturer
Federa Limoges Sas, Zi NordModel number
NACatalog number
NA
Lot number
CE074-01, CE081-01
Product problems
- Unknown (for use when the device problem is not known)
Patient
51 YR
- Thrombosis
Narrative
Description of Event or Problem
A REPORT HAS BEEN RECEIVED IN JULY 2005 FROM AN INVESTIGATOR CONCERNING A PATIENT WHO HAD BEEN ENROLLED IN AN INVESTIGATOR INITIATED STUDY FOR HEPATIC GRAFT PRESERVATION. THE PATIENT HAS A MEDICAL HISTORY SIGNIFICANT FOR LIVER CIRRHOSIS AND ALCOHOL USE. IN 2004, TWO DAYS AFTER THE LIVER TRANSPLANTATION, THE PATIENT SUFFERED FROM THROMBOSIS IN THE LEFT PORTAL BRANCH OF THE LIVER. CONCOMITANT MEDICATIONS CONSISTED OF TARCROLIMUS, MYCOPHENOLATE MOFETIL, AND CORTICOSTEROID THERAPY. IN THE OPINION OF THE INVESTIGATOR, THE EVENT IS RELATED TO THE SURGICAL INTERVENTION RATHER THEN THE USE CELSIOR. IN THE OPINION OF THE SPONSOR OF THE STUDY, THE EVENT IS UNEXPECTED AND POSSIBLY RELATED TO THE USE OF CELSIOR.