BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 18020100 · Received October 27, 2023

    Report

    Report Number
    3002836339-2023-00093
    Event Type
    Death
    Date Received
    October 27, 2023
    Date of Event
    April 20, 2023
    Report Date
    December 15, 2023
    Manufacturer
    VERICEL
    Product Code
    OCE
    PMA / PMN Number
    990200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT RECEIVED INITIALLY FROM A HEALTHCARE PROFESSIONAL ON 20-APR-2023, REGARDING A 22-YEAR-OLD FEMALE PATIENT, WHO DIED BEFORE THE THIRD EPICEL APPLICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION DETAILS WERE NOT REPORTED. ON (B)(6) 2023, THE PATIENT RECEIVED 32 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) (LOT NUMBER: EE03095-21, EXPIRATION DATE: 13-FEB-2023) FOR BURN. ON (B)(6) 2023, THE PATIENT RECEIVED 25 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) (LOT NUMBER: EE03095-22, EXPIRATION DATE: 16-MAR-2023) FOR BURN. ON (B)(6) 2023, 35 GRAFTS OF EPICEL WERE SHIPPED (30 ORDERED AND 5 EXTRA). ON THE SAME DATE, UPON OPENING THE CONTAINER, IT WAS FOUND THAT EPICEL GRAFTS (CULTURED EPIDERMAL AUTOGRAFTS; LOT NUMBER: EE03095-23, EXPIRATION DATE: 20-APR-2023) WERE BAD AND SKIN WAS COMPLETELY DETACHED FROM BACKINGS ON TEN GRAFTS. IT WAS REPORTED THAT THE GRAFTS WERE UNUSABLE. ON THE SAME DATE, IT WAS REPORTED THAT THE PATIENT EXPIRED, BEFORE BEING GRAFTED WITH EPICEL, BECAUSE OF A COMPROMISED AIRWAY (PT: OBSTRUCTIVE AIRWAYS DISORDER). IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT NO GRAFTS WERE USED ON THE PATIENT ON THIS DAY. THE REPORTER DID NOT PROVIDE SERIOUSNESS AND CAUSALITY ASSESSMENT FOR THE REPORTED EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APR-2023, 25-APR-2023, 26-APR-2023 AND 04-MAY-2023 AND PROCESSED TOGETHER WITH THE INITIAL. THE NEED FOR SIGNIFICANT CORRECTION WAS IDENTIFIED ON 27-SEP-2023 AND INCLUDED RECODING SUSPECT DRUG EPICEL FROM DEVICE TO COMBINATION PRODUCT. THE NEED FOR SIGNIFICANT CORRECTION WAS IDENTIFIED ON 04-DEC-2023 AND INCLUDED THE DELETION OF THE EVENT OF PRODUCT QUALITY ISSUE AND THE CHANGE OF EXPECTEDNESS FROM UNLISTED TO LISTED FOR EVENT OBSTRUCTIVE AIRWAYS DISORDER. THE PRODUCT QUALITY ISSUE WAS REMOVED BECAUSE THE PATIENT DID NOT RECEIVE THE THIRD TREATMENT OF EPICEL ON THE SCHEDULED DATE. ADDITIONAL INFORMATION WAS RECEIVED ON 14-DEC-2023 AND PROCESSED TOGETHER WITH THE SIGNIFICANT CORRECTION. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: OBSTRUCTIVE AIRWAY DISORDER IS CONSIDERED EXPECTED FOR EPICEL. A COMPROMISED AIRWAY IS A COMPLICATION OF EXTENSIVE BURNS. THERE IS NO EVIDENCE TO SUGGEST A REASONABLE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL. THEREFORE, CAUSALITY IS ASSESSED AS NOT RELATED. THE CASE IS SERIOUS DUE TO THE FATAL OUTCOME. THE REPORT DID NOT QUALIFY AS A MEDICAL DEVICE REPORT OR A 15-DAY-REPORT.

    Additional Manufacturer Narrative · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT RECEIVED INITIALLY FROM A HEALTHCARE PROFESSIONAL ON (B)(6) 2023, REGARDING A 22-YEAR-OLD FEMALE PATIENT, WHO DIED BEFORE THE THIRD EPICEL APPLICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION DETAILS WERE NOT REPORTED. ON (B)(6) 2023, (B)(6) 2023 AND (B)(6) 2023, QC LOT RELEASE ASSAYS (GRAFT INSPECTION QC2-027, DUAL STAIN QC2-094, ENDOTOXIN QC2-010, STERILITY PRE-RELEASE QC2-005, STERILITY FINAL PRODUCT QC2-012) AND ENVIRONMENTAL RESULTS (MANUFACTURING: GRADE A (FINGERTIPS - LEFT AND RIGHT, BSC HOOD SURFACE, SETTLING PLATE - LEFT AND RIGHT, SLEEVE - LEFT AND RIGHT) AND GRADE B (VIABLE AIR PARTICULATES AND NONVIABLE AIR PARTICULATES) AND QC STERILITY: GRADE A (FINGERTIPS - LEFT AND RIGHT, BSC HOOD SURFACE, SETTLING PLATE - LEFT AND RIGHT, SLEEVE - LEFT AND RIGHT)) WERE PERFORMED. ALL RESULTS WERE REPORTED AS ''PASS''. QC LOT RELEASE ASSAY (IMPLEMENTED 29-SEP-2019) 3T3 RESIDUAL ASSAY Q2C-136 WAS REPORTED AS 0.24 - PASS; 0.28 - PASS, 0.26 - PASS. ON (B)(6) 2023, THE PATIENT RECEIVED 32 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) (LOT NUMBER: UNKNOWN, EXPIRATION DATE: 13-FEB-2023) FOR BURN. ON (B)(6) 2023, THE PATIENT RECEIVED 25 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) (LOT NUMBER: UNKNOWN, EXPIRATION DATE: 16-MAR-2023) FOR BURN. ON (B)(6) 2023, 35 GRAFTS OF EPICEL WERE SHIPPED (30 ORDERED AND 5 EXTRA). ON THE SAME DATE, UPON OPENING THE CONTAINER, IT WAS FOUND THAT EPICEL GRAFTS (CULTURED EPIDERMAL AUTOGRAFTS; LOT NUMBER: EE03095-23, EXPIRATION DATE: 20-APR-2023) WERE BAD AND SKIN WAS COMPLETELY DETACHED FROM BACKINGS ON TEN GRAFTS (PT: PRODUCT QUALITY ISSUE). IT WAS REPORTED THAT THE GRAFTS WERE UNUSABLE. ON THE SAME DATE, IT WAS REPORTED THAT THE PATIENT EXPIRED, PRIOR TO BEING GRAFTED WITH EPICEL, BECAUSE OF COMPROMISED AIRWAY (PT: OBSTRUCTIVE AIRWAYS DISORDER). IT WAS UNKNOWN IF THE AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT NO GRAFTS WERE USED ON THE PATIENT. THE REPORTER DID NOT PROVIDE SERIOUSNESS AND CAUSALITY ASSESSMENT FOR THE REPORTED EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APR-2023, 25-APR-2023, 26-APR-2023 AND 04-MAY-2023 AND PROCESSED TOGETHER WITH THE INITIAL. NEED FOR SIGNIFICANT CORRECTION WAS IDENTIFIED ON 27-SEP-2023 AND INCLUDED RECODING SUSPECT DRUG EPICEL FROM DEVICE TO COMBINATION PRODUCT. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: OBSTRUCTIVE AIRWAY DISORDER IS UNLISTED FOR EPICEL ACCORDING TO DFU, WHILST PRODUCT QUALITY ISSUE IS CONSIDERED AS LISTED. A 22-YEAR-OLD FEMALE PATIENT RECEIVED 57 EPICEL GRAFTS IN TOTAL FOR BURN. ADDITIONAL 35 GRAFTS WERE SHIPPED AND UPON OPENING THE CONTAINER IT WAS FOUND THAT TEN GRAFTS WERE BAD AND SKIN WAS COMPLETELY DETACHED FROM BACKING. ON THE SAME DAY THE PATIENT EXPIRED DUE TO COMPROMISED AIRWAY. DUE TO LIMITED INFORMATION REGARDING CIRCUMSTANCES LEADING TO AIRWAY OBSTRUCTION, PATIENT'S RELEVANT MEDICAL HISTORY AND AUTOPSY RESULTS, THE EVALUATION DID NOT FIND ENOUGH EVIDENCE TO SUGGEST A REASONABLE CAUSAL RELATIONSHIP BETWEEN OBSTRUCTIVE AIRWAY DISORDER AND EPICEL, THEREFORE RENDERING THE CAUSALITY AS NOT RELATED. PRODUCT QUALITY ISSUE IS ASSESSED AS POSSIBLY RELATED. THE REPORT DID NOT QUALIFY AS A MEDICAL DEVICE REPORT, BUT QUALIFIES AS A 15-DAY-REPORT SINCE OBSTRUCTIVE AIRWAY DISORDER IS UNEXPECTED AND SERIOUS.

    Description of Event or Problem · 0

    AIRWAY COMPROMISED, PATIENT EXPIRED [OBSTRUCTIVE AIRWAYS DISORDER];

    Description of Event or Problem · 0

    AIRWAY COMPROMISED, PATIENT EXPIRED [OBSTRUCTIVE AIRWAYS DISORDER]; SKIN DETACHED FROM BACKINGS ON 10 GRAFTS [PRODUCT QUALITY ISSUE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700194 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE VERICEL EE03095-22

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Death