Description of Event or Problem · 1
RESPIRATORY FAILURE [RESPIRATORY FAILURE]. ABDOMINAL COMPARTMENT SYNDROME [ABDOMINAL COMPARTMENT SYNDROME]. DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS [INTESTINAL ISCHAEMIA]. DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS [GASTROINTESTINAL NECROSIS]. SEPTIC SHOCK [SEPTIC SHOCK]. CASE NARRATIVE: CASE REFERENCE NUMBER US-VCEL-20-002972 IS A SPONTANEOUS CASE INITIALLY RECEIVED FROM A PHYSICIAN ON 30-JUN-2020 WITH ADDITIONAL INFORMATION RECEIVED ON 06-JUL-2020 AND CONCERNS A (B)(6)-YEAR-OLD FEMALE PATIENT ((B)(6) HEIGHT AND (B)(6) KG WEIGHT). *THE PATIENT'S MEDICAL HISTORY INCLUDED 32.5% BURN FROM A HOUSE FIRE WITH MILD INHALATION INJURY*. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED DUE TO INJURY. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2020, THE PATIENT WAS TREATED WITH EPICEL FOR *32.5% BURN FROM A HOUSE FIRE WITH MILD INHALATION INJURY.* THE EPICEL BATCH NUMBER WAS EE02641. ON AN UNSPECIFIED DATE IN (B)(6) 2020, THE PATIENT EXPERIENCED ABDOMINAL COMPARTMENT SYNDROME, PROBABLE ISCHEMIC BOWEL WITH SEPTIC SHOCK DUE TO WHICH WENT TO OPERATING ROOM (OR) ON (B)(6) 2020 FOR ABDOMINAL SURGERY. DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS WAS FOUND. BOWEL WAS WASHOUT. *ON AN UNSPECIFIED DATE IN (B)(6) 2020, THE PATIENT ALSO EXPERIENCED RESPIRATORY FAILURE.* ON (B)(6) 2020 AT 17:00, THE PATIENT RETURNED TO SURGERY. ISCHEMIA AND NECROSIS WERE MORE WIDESPREAD THAN TWO DAYS AGO. ON (B)(6) 2020, AFTER FAMILY CONFERENCE PATIENT TRANSFERRED TO HOSPICE AT 16:12. ON (B)(6) 2020 AT 18:00, THE PATIENT DIED *DUE TO RESPIRATORY FAILURE. AUTOPSY WAS NOT PERFORMED.* *AT THE TIME OF PATIENT'S DEATH, THE OUTCOMES FOR THE EVENTS OF DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS AND SEPTIC SHOCK WERE CONSIDERED AS NOT RESOLVED, WHILE THE OUTCOME FOR THE EVENT OF ABDOMINAL COMPARTMENT SYNDROME WAS UNKNOWN.* THE EVENT OF RESPIRATORY FAILURE IS CONSIDERED AS SERIOUS DUE TO DEATH. PER COMPANY, THE EVENTS OF ABDOMINAL COMPARTMENT SYNDROME, DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS AND SEPTIC SHOCK WERE CONSIDERED AS SERIOUS DUE TO SERIOUSNESS CRITERION OF MEDICAL SIGNIFICANCE. *THE REPORTER ASSESSED THE EVENTS OF ABDOMINAL COMPARTMENT SYNDROME, DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS AND SEPTIC SHOCK AS NOT RELATED TO EPICEL AND DID NOT PROVIDE CAUSALITY ASSESSMENT FOR THE EVENT OF RESPIRATORY FAILURE. PER REPORTER, THE PATIENT'S DEATH WAS NOT RELATED TO EPICEL.* FOLLOW-UP INFORMATION RECEIVED FROM CLINICAL RESEARCH COORDINATOR ON 08-JUL-2020: NEW REPORTER AND NEW ADVERSE EVENTS: ABDOMINAL COMPARTMENT SYNDROME, SEPTIC SHOCK, DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS WERE REPORTED. LOT NUMBER OF EPICEL, INFORMATION ABOUT PATIENT SURGERY AND INFORMATION ABOUT PATIENT¿S DEATH WERE PROVIDED. FOLLOW-UP INFORMATION RECEIVED FROM CLINICAL RESEARCH COORDINATOR ON 28-JUL-2020: CAUSE OF PATIENT'S DEATH AND INFORMATION ON AUTOPSY PROVIDED, NEW EVENT OF RESPIRATORY FAILURE ADDED. NEW REPORTER AND INDICATION FOR EPICEL PROVIDED. INFORMATION ON OUTCOMES AND REPORTER'S CAUSALITY ASSESSMENT FOR THE EVENTS OF ABDOMINAL COMPARTMENT SYNDROME, DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS AND SEPTIC SHOCK PROVIDED. ALL FOLLOW-UP INFORMATION IS BLENDED INTO THE CASE NARRATIVE ABOVE, WITH THE LATEST INFORMATION PRESENTED BETWEEN ASTERISKS (*) CASE COMMENTS: RESPIRATORY FAILURE WITH FATAL OUTCOME, ABDOMINAL COMPARTMENT SYNDROME, BOWEL NECROSIS AND BOWEL ISCHAEMIA ARE UNLISTED, WHILE SEPTIC SHOCK IS LISTED FOR EPICEL AS PER THE DIRECTIONS FOR USE (DFU). REPORTEDLY, THE PATIENT EXPERIENCED RESPIRATORY FAILURE AT SOME POINT AFTER EPICEL IMPLANTATION PROCEDURE. FURTHERMORE, SEVEN DAYS AFTER EPICEL CULTURED EPIDERMAL AUTOGRAFTS HAD BEEN APPLIED, THE PATIENT DEVELOPED ABDOMINAL COMPARTMENT SYNDROME WITH SEPTIC SHOCK. DIFFUSE ISCHEMIC BOWEL WITH PATCHY AREAS OF NECROSIS WAS FOUND DURING ABDOMINAL SURGERY. TWO DAYS LATER ISCHEMIA AND NECROSIS WERE MORE WIDESPREAD AND THE PATIENT DIED ON THE VERY NEXT DAY DUE TO RESPIRATORY FAILURE. TAKING INTO CONSIDERATION THAT THIS PATIENT HAD ALREADY BURNS ALONGSIDE WITH INHALATION INJURY, THE REPORTED EVENTS MOST PROBABLY OCCURRED AS COMPLICATIONS OF UNDERLYING BURNS, THE CAUSALITY IS ASSESSED AS UNLIKELY RELATED FOR ALL REPORTED EVENTS. THE CASE IS SERIOUS DUE TO FATAL OUTCOME. AS OVERALL SERIOUSNESS AND EXPECTEDNESS OF THE CASE ARE SERIOUS AND UNEXPECTED, THIS FOLLOW-UP VERSION OF THE REPORT NOW QUALIFIES AS 15-DAY REPORT. THE REPORT DOES NOT QUALIFY AS AN MDR.