CELSIOR

Description of Event or Problem

THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE HAS BEEN CROSS REFERRED WITH CASE (B)(4) (CLUSTER). THIS CASE INVOLVES 5 PTS WHO EXPERIENCED DELAYED GRAFT FUNCTION AFTER UNDERGOING HEART TRANSPLANTATIONS, WHICH WERE PRESERVED WITH CELSIOR ORGAN PRESERVATION SOLUTION (CELSIOR). NO PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON UNK DATES, THE HEARTS FOR TRANSPLANT WERE PRESERVED IN CELSIOR, SOLUTION FOR ORGAN PRESERVATION. ON UNK DATES, THE PTS UNDERWENT HEART TRANSPLANT. ON UNK DATES, AFTER AN UNSPECIFIED LATENCY PERIOD, THE PTS HAD DELAYED GRAFT FUNCTION. IT WAS REPORTED THAT THE PTS EXPECTED TO HAVE GOOD OUTCOMES BUT THEY DID NOT. NO CORRECTIVE TREATMENT WAS REPORTED. OUTCOME: UNK. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND THE RESULTS WERE PENDING FOR THE SAME.

Additional Manufacturer Narrative

SERIOUSNESS CRITERIA: MEDICAL SIGNIFICANT. PHARMACOVIGILANCE COMMENT: (B)(4) COMMENT DATED (B)(4) 2014: THIS CASE CONCERNS (B)(6) PTS WHO DEVELOPED DELAYED GRAFT FUNCTION AFTER UNDERGOING HEART TRANSPLANTATIONS AFTER USING CELSIOR ORGAN PRESERVATION SOLUTION FOR ORGAN PRESERVATION. ALTHOUGH THE ROLE OF THE ORGAN PRESERVATION SOLUTION CANNOT BE RULED OUT BASED ON THE DEVICE EVENT TEMPORAL RELATIONSHIP; HOWEVER, LACK OF DETAILED INFORMATION ABOUT MEDICAL HISTORY, LAB DATA, ANY CONCURRENT MEDICAL ILLNESSES, CLINICAL COURSE ETC. OF THE PT PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.