CELSIOR

Description of Event or Problem

THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A HEALTH CARE PROFESSIONAL (OTHER). THIS CASE WAS CROSS REFERENCED WITH (B)(4) (CLUSTER). THIS IS A SUMMARY CASE OF 05 PATIENTS WHO DEVELOPED DELAYED GRAFT FUNCTION AFTER UNDERGOING HEART TRANSPLANTATIONS WHICH WERE PRESERVED WITH CELSIOR ORGAN PRESERVATION SOLUTION (CELSIOR). THE MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED FOR ALL THE PATIENTS. ON UNKNOWN DATES, THE HEARTS FOR TRANSPLANT WERE PRESERVED IN CELSIOR ORGAN PRESERVATION SOLUTION. ON UNKNOWN DATES, THE PATIENTS UNDERWENT HEART TRANSPLANT. ON UNSPECIFIED DATES, AFTER UNKNOWN TIME FRAME, THESE PATIENTS HAD DELAYED GRAFT FUNCTION. REPORTEDLY, THEY EXPECTED TO HAVE GOOD OUTCOMES BUT THEY DID NOT. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNK. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT (IME). A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME.

Additional Manufacturer Narrative

PHARMACOVIGILANCE COMMENT: SANOFI COMPANY DATED (B)(4) 2014: THIS CASE CONCERNS A GROUP OF FIVE PATIENTS WHO HAD DELAYED GRAFT FUNCTION 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 PATIENT PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.