CELSIOR
Received Sep 7, 2004 · Event occurred Apr 2, 2004
Report 2950168-2004-00002 · MDR key 542671
Device
Generic name
Organ Preservation Solution
Manufacturer
Federa Limoges Sas, Zi NordModel number
NACatalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
61 YR
- Thrombosis
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'S MEDICAL HISTORY WAS NOT PROVIDED. THE PT UNDERWENT LIVER TRANSPLATATION IN 2004 (DO). THEY EXPERIENCED A HEPATIC ARTERY THROMBOSIS THE FOLLOWING MONTH. AT THE TIME OF THIS REPORT PT'S OUTCOME WAS UNK. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO CELSIOR, BUT HE MADE THE REMARK THAT ARTERIAL ANASTOMOSIS WAS DIFFICULT WITH AORTIC IMPLANTATION AND HOMOGRAFT.