D
Patient 1
BASED ON ADD'L INFO RECEIVED ON AUGUST 20, 2014, THIS CASE INITIALLY PROCESSED AS A RUMOR CASE OF UNSPECIFIED PTS IS NOW PROCESSED AS AN INDIVIDUAL PT CASE. THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A PHYSICIAN. THIS CASE HAS BEEN CROSS REFERRED WITH (B)(4). THIS CASE CONCERNS A PT OF UNK DEMOGRAPHICS WHO HAD GRAFT FAILURE AFTER THE USE OF CELSIOR ORGAN PRESERVATION SOLUTION (CELSIOR). NO RELEVANT MEDICAL HISTORIES, PAST DRUGS, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED FOR ANY OF THE PTS. ON AN UNK DATE, THE PT UNDERWENT HEART TRANSPLANT DURING WHICH CELSIOR ORGAN PRESERVATION SOLUTION, SOLUTION FOR ORGAN PRESERVATION (LOT / BATCH NUMBER AND EXPIRATION DATE: UNK) WAS USED FOR ORGAN PRESERVATION. IT WAS REPORTED THAT THE PT HAD DIFFICULTY IN COMING OFF THE BY-PASS MACHINE IN THE OPERATION ROOM AND "PRIMARY GRAFT FAILURE" WAS SEEN IN THESE 6-7 PTS. IT WAS ALSO REPORTED THAT, CLUSTER OF ABOUT 10 HEART TRANSPLANT WERE DONE AND 5 OF THOSE ENDED WITH PRIMARY GRAFT FAILURES (4 OUT OF 5 GRAFT FAILURES RESULTED IN DEATH. IT WAS REPORTED THAT HEART GRAFTS HAD FAILED OVER THE PERIOD SINCE 2013. NO CORRECTIVE TREATMENT WAS REPORTED. OUTCOME: UNK. SERIOUSNESS CRITERIA: MEDICALLY SIGNIFICANT. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. ADD'L INFO WAS RECEIVED ON AUGUST 20, 2014 FROM THE PHYSICIAN AND THE CASE WAS UPDATED FROM RUMOR CASE TO AN INDIVIDUAL PT CASE. THE EVENT ONSET DATE WAS ADDED AND THE SERIOUSNESS CRITERIA WAS UPDATED FROM IMPORTANT MEDICAL EVENT TO MEDICALLY SIGNIFICANT. TEXT AMENDED ACCORDINGLY.