EXPIRED [DEATH]. CASE DESCRIPTION: THIS SPONTANEOUS DEVICE CASE FROM UNITED STATES WAS REC'D ON (B)(6) 2015 FROM A HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) MALE PT WHO EXPIRED AFTER GRAFTING WITH 96 SHEETS OF EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS, CONCOMITANT MEDICATION WERE REPORTED. ON (B)(6) 2015, A BIOPSY OF PT WAS TAKEN. ON (B)(6) 2015, THE PT WAS GRAFTED WITH 96 SHEETS OF EPICEL GRAFTS BATCH/LOT NUMBER EE0190. ON (B)(6) 2015, THE PT EXPIRED. THE TYPE OF BURN WAS UNK. TOTAL PERCENTAGE OF BURN SURFACE AREA WAS 79 PERCENT. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATION, SIGNS, SYMPTOMS, BIOPSY RESULTS, BASELINE DATA, DIAGNOSIS, CAUSE OF DEATH AND AUTOPSY RESULTS WERE NOT REPORTED. QC STERILITY TEST RESULTS OF PRE-RELEASE SAMPLE TYPE FROM (B)(6) 2015 TO (B)(6) 2015 AND OF FINAL PROD SAMPLE TYPE FROM (B)(6) 2015 TO (B)(6) 2015 WERE BOTH NEGATIVE. ENVIRONMENTAL RESULTS: PERSONNEL MONITORING OF MFG PASSED IN GRADE 1 AND B PARAMETERS AND PERSONNEL MONITORING OF QC STERILITY PASSED GRADE A PARAMETER. THE FOLLOWING QUALITY CONTROL FINAL PROD RELEASE TEST RECORDS WERE REVIEWED: QC2-027 (GRAFT INSPECTION) RESULT GRAFTS AVAILABLE FOR SHIPMENT; QC2-094 (DUAL STAIN ASSAY) RESULT- PERCENT VIABLE; AND QC2-010 (ENDOTOXIN ASSAY) RESULT-LESS THAN 1 EU/ML. IT WAS REPORTED THAT ALL TESTING WERE COMPLETED AS EXPECTED AND NO ERRORS OCCURRED DURING TESTING. ALL TEST RECORDS REPORTED ABOVE WERE CONFIRMED TO BE ACCURATE. OUTCOME: FATAL. SERIOUSNESS CRITERION: DEATH. THE REPORTER DID NOT PROVIDE THE CASUAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. HOWEVER, AS PER THE CONDITIONS OF THE HUMANITARIAN DEVICE EXEMPTION, THAT "UNLESS DEATH IS SPECIFICALLY REPORTED AS "NOT RELATED" TO EPICEL BY THE REPORTER, IT WILL BE CONSIDERED CAUSALLY RELATED", THIS EVENT IS CONSIDERED AS RELATED TO EPICEL GRAFTS. WITH THE LIMITED INFO AVAILABLE, THE COMPANY ASSESSED THAT THE DEATH COULD BE POSSIBLY RELATED TO EPICEL THOUGH THERE IS ALSO A STRONG POSSIBILITY OF THE DEATH OCCURRING DUE TO THE BURNS OR COMPLICATIONS OF THE SURGERY. SEE SCANNED PAGE.
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Patient 1
THIS SPONTANEOUS DEVICE CASE FROM UNITED STATES WAS RECEIVED ON 27-APR-2015 FROM A HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO EXPIRED AFTER GRAFTING WITH 96 SHEETS OF EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS, CONCOMITANT MEDICATION WERE REPORTED. ON (B)(6) 2015, A BIOPSY OF THE PATIENT WAS TAKEN. ON (B)(6) 2015, THE PATIENT WAS GRAFTED WITH 96 SHEETS OF EPICEL GRAFTS BATCH/LOT NUMBER EE01906. ON (B)(6) 2015, THE PATIENT EXPIRED. THE TYPE OF BURN WAS UNKNOWN. TOTAL PERCENTAGE OF BURN SURFACE AREA WAS 79 PERCENT. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATION, SIGNS, SYMPTOMS, BIOPSY RESULTS, BASELINE DATA, DIAGNOSIS, CAUSE OF DEATH AND AUTOPSY RESULTS WERE NOT REPORTED. QC STERILITY TEST RESULTS OF PRE-RELEASE SAMPLE TYPE FROM (B)(6) 2015 AND OF FINAL PRODUCT SAMPLE TYPE FROM (B)(6) 2015 WERE BOTH NEGATIVE. ENVIRONMENTAL RESULTS: PERSONNEL MONITORING OF MANUFACTURING PASSED IN GRADE A AND B PARAMETERS AND PERSONNEL MONITORING OF QC STERILITY PASSED GRADE A PARAMETER. THE FOLLOWING QUALITY CONTROL FINAL PRODUCT RELEASE TEST RECORDS WERE REVIEWED: QC2-027 (GRAFT INSPECTION)-RESULT- 96 GRAFTS AVAILABLE FOR SHIPMENT; QC2-094 (DUAL STAIN ASSAY)-RESULT-50-75 PERCENT VIABLE; AND QC2-010 (ENDOTOXIN ASSAY)-RESULT: LESS THAN 1 EU/ML. IT WAS REPORTED THAT ALL TESTING WERE COMPLETED AS EXPECTED AND NO ERRORS OCCURRED DURING TESTING. ALL TEST RECORDS REPORTED ABOVE WERE CONFIRMED TO BE ACCURATE. OUTCOME: FATAL. SERIOUSNESS CRITERION: DEATH. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. HOWEVER, AS PER THE CONDITIONS OF THE HUMANITARIAN DEVICE EXEMPTION, THAT "UNLESS DEATH IS SPECIFICALLY REPORTED AS "NOT RELATED" TO EPICEL BY THE REPORTER, IT WILL BE CONSIDERED CAUSALLY RELATED", THIS EVENT IS CONSIDERED AS RELATED TO EPICEL GRAFTS. WITH THE LIMITED INFORMATION AVAILABLE, THE COMPANY ASSESSED THAT THE DEATH COULD BE POSSIBLY RELATED TO EPICEL THOUGH THERE IS ALSO A STRONG POSSIBILITY OF THE DEATH OCCURRING DUE TO THE BURNS OR COMPLICATIONS OF THE SURGERY. ADDITIONAL FOLLOW-UP INFORMATION RECEIVED ON 21-NOV-2016 FROM A PHYSICIAN. THE PHYSICIAN REPORTED THAT THE PATIENT HAD 80 PERCENT TBSA (TOTAL BODY SURFACE AREA) THIRD DEGREE BURN INJURY FROM ACETYLENE TORCH-GAS EXPLOSION. NO CLINICAL COURSE WAS DONE AND STATED THAT THE ENTIRE HOSPITALIZATION WAS 'ROCKY' AND THE PATIENT WAS MAINTAINED ON HEMODIALYSIS. THE PATIENT WAS TREATED WITH LEVOPHED (NOREPINEPHRINE BITARTRATE) FOR ALMOST ENTIRE HOSPITALIZATION FROM (B)(6) 2015 AND REPORTED THAT THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK. NO AUTOPSY WAS PERFORMED. AS PER REPORTER THE DEATH WAS NOT DUE TO EPICEL. THE COMPANY CONSIDERED THAT THE DEATH WAS NOT RELATED TO EPICEL BUT WAS DUE TO CARDIOGENIC SHOCK SECONDARY TO THE BURN INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.