CELSIOR
Received Sep 7, 2004 · Event occurred Jul 12, 2004
Report 2950168-2004-00003 · MDR key 542662
Device
Generic name
Organ Preservation Solution
Manufacturer
Federa Limoges SasModel number
NACatalog number
NA
Lot number
CE074-01
Product problems
- Unknown (for use when the device problem is not known)
Patient
35 YR
- Thrombosis
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
HEPATIC ARTERY THROMBOSIS. A REPORT HAS BEEN RECEIVED FROM AN INVESTIGATOR CONCERNING A PT WHO HAD BEEN ENROLLED IN AN INVESTIGATOR INITIATED STUDY ASSESSING EFFICACY OF CELSIOR FOR HEPATIC GRAFT PRESERVATION (IS-106-P004). THE PT HAD A MEDICAL HISTORY OF CIRRHOSIS DUE TO HBV, HCV, AND DELTA VIRUS HEPATITIS. THEIR CONCOMITANT MEDICATION INCLUDED CORTANCYL, FK 506, LAMIVUDINE AND OMEPRAZOLE. THE PT UNDERWENT LIVER TRANSPLANTATION IN 2004 (D0). THEY EXPERIENCED AN HEPATIC ARTERY THROMBOSIS THE FOLLOWING MONTH (D24) WITH ACUTE REJECTION. THE REGULAR DOPPLER FAILED TO SHOW ANY ARTERIAL SIGNAL. THE DIAGNOSIS WAS CONFIRMED BY CT-SCAN. AT THE TIME OF THIS REPORT PT'S OUTCOME WAS UNKNOWN. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO CELSIOR ALTHOUGH DUBIOUS AND ALSO POSSIBLY RELATED TO ACUTE REJECTION.