BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 11999614 · Received June 15, 2021

    Report

    Report Number
    3002836339-2021-00039
    Event Type
    Death
    Date Received
    June 15, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 15, 2021
    Manufacturer
    VERICEL
    Product Code
    OCE
    PMA / PMN Number
    990200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CASE REFERENCE NUMBER (B)(4) IS A SERIOUS SPONTANEOUS REPORT INITIALLY RECEIVED FROM A BURN THERAPY SPECIALIST VIA CUSTOMER CARE ON 20-MAY-2021 WHICH CONCERNS A *(B)(6) YEARS OLD FEMALE PATIENT* WHO EXPERIENCED *MYOCARDIAL INFARCTION (MI) AND MULTI ORGAN FAILURE.* MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2021, 144 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02761, EXPIRATION DATE: 04-MAY-2021) WERE USED ON THE PATIENT FOR THERMAL BURNS. ON (B)(6) 2021, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS *MYOCARDIAL INFARCTION (MI) AND MULTI ORGAN FAILURE. NO AUTOPSY WAS PERFORMED.* THE REPORTER'S CAUSALITY ASSESSMENT WAS *PROVIDED AS NOT RELATED TO EPICEL.* NO FURTHER INFORMATION WAS PROVIDED. ALL FOLLOW-UP INFORMATION IS INCLUDED IN THE CASE NARRATIVE ABOVE, WITH THE LATEST INFORMATION PRESENTED BETWEEN ASTERISKS (*). FOLLOW UP INFORMATION RECEIVED FROM A BURN THERAPY SPECIALIST ON 01-JUN-2021: THE PATIENT'S INITIALS, GENDER, DOB AND YEARS WERE PROVIDED. AUTOPSY INFORMATION UPDATED. CAUSE OF DEATH PROVIDED. CAUSALITY ASSESSMENT UPDATED TO NOT RELATED. CASE COMMENT: MYOCARDIAL INFARCTION IS UNEXPECTED AND MULTIPLE ORGAN DYSFUNCTION SYNDROME IS EXPECTED ACCORDING TO THE EPICEL DFU. REPORTEDLY, 15 DAYS AFTER GRAFTING WITH EPICEL THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND MULTI ORGAN FAILURE, AND DIED. THE PATIENT WAS GRAFTED WITH 144 GRAFTS OF EPICEL FOR THERMAL BURNS, SO IT COULD BE ASSUMED THAT BURNS WERE EXTENSIVE WHICH IS THE MAJOR CONFOUNDER FOR THE EVENTS. NO INFORMATION REGARDING RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CLINICAL COURSE WAS PROVIDED. HAVING IN MIND UNDERLYING EXTENSIVE BURNS AND THE FACT THAT THERE WAS NO EVIDENCE TO SUGGEST THAT EPICEL CAUSED THE EVENTS, CAUSALITY IS IN LINE WITH REPORTER'S AND ASSESSED AS NOT RELATED TO EPICEL. THE CASE IS SERIOUS DUE TO FATAL OUTCOME. THE CASE DID NOT QUALIFY AS AN MDR. HOWEVER, DUE TO SERIOUS UNEXPECTED EVENT MYOCARDIAL INFARCTION, THE REPORT QUALIFIED AS A 15-DAY REPORT.

    Description of Event or Problem · 1

    MYOCARDIAL INFARCTION (MI) [MYOCARDIAL INFARCTION]; MULTI ORGAN FAILURE [MULTI ORGAN FAILURE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898955 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE VERICEL EE02761

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| O