EPICEL
Report
- Report Number
- 3002836339-2021-00044
- Event Type
- Death
- Date Received
- August 19, 2021
- Report Date
- July 29, 2022
- Manufacturer
- VERICEL
- Product Code
- OCE
- PMA / PMN Number
- 990200
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CASE REFERENCE NUMBER (B)(4) IS A SERIOUS SPONTANEOUS REPORT INITIALLY RECEIVED FROM A NURSE ON 05-AUG-2021, WITH ADDITIONAL INFORMATION RECEIVED ON 06-AUG-2021, AND ON 10-AUG-2021 WHICH CONCERNS A 63 YEARS OLD MALE PATIENT WHO EXPERIENCED ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION- LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET, CARDIO-PULMONARY FAILURE AND SEPSIS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS SICK WITH MULTIPLE ISSUES. ON 31-JAN-2021, 10-FEB-2021, 25-FEB-2021 AND 18-MAR-2021, 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 <0.1 - PASS; 0.14 - PASS, 0.12 - PASS, <0.1 - PASS. ON (B)(6) 2021, 129 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (B)(6), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR *80% OF TOTAL BODY AREA (TBSA)* THERMAL BURNS. ON (B)(6) 2021, 84 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (B)(6), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR *80% OF TOTAL BODY AREA (TBSA)* THERMAL BURNS. ON (B)(6) 2021, 82 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (B)(6), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR *80% OF TOTAL BODY AREA (TBSA)* THERMAL BURNS. ON (B)(6) 2021, 72 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (B)(6), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR *80% OF TOTAL BODY AREA (TBSA)* THERMAL BURNS. *ON (B)(6), 2021*, LATE AFTERNOON, * THE PATIENT WAS PLACED ON HOSPICE.* ON (B)(6), 2021, AT 11:57, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CARDIO-PULMONARY FAILURE AND SEPSIS. IT WAS UNKNOWN IF THE 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 BLENDED INTO THE CASE NARRATIVE ABOVE, WITH THE LATEST INFORMATION PRESENTED BETWEEN ASTERISKS (*). FOLLOW-UP INFORMATION RECEIVED FROM SENIOR QUALITY CONTROL MANAGER ON 12-AUG-2021: NEW INFORMATION INCLUDED QC TESTS. FOLLOW-UP INFORMATION RECEIVED ON 17-SEP-2021: NEW INFORMATION INCLUDED INDICATION FOR EPICEL. DATE WHEN PATIENT WAS PLACED IN HOSPICE. CONFIRMATION THAT NO FURTHER INFORMATION WAS AVAILABLE CASE COMMENT: SEPSIS IS EXPECTED, WHILE ENDOCARDITIS, CARDIOPULMONARY FAILURE AND MITRAL VALVE INCOMPETENCE ARE UNEXPECTED ACCORDING TO THE EPICEL DFU. THE PATIENT DIED ALMOST FIVE MONTHS AFTER THE LAST EPICEL GRAFTING DUE TO CARDIO-PULMONARY FAILURE AND SEPSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MITRAL VALVE LEAFLET, BUT EXACT TIMELINE WAS NOT PROVIDED. THE PATIENT WAS SICK WITH MULTIPLE ISSUES AND HAD THERMAL BURNS. EXTENSIVE BURNS COULD HAVE PROVIDED AN ALTERNATIVE AETIOLOGY FOR ENDOCARDITIS AND SEPSIS WHICH CAUSED CARDIO-PULMONARY FAILURE. NO INFORMATION REGARDING CLINICAL COURSE WAS PROVIDED. HAVING IN MIND NOT SUGGESTIVE TEMPORAL RELATIONSHIP 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 MEDICAL SIGNIFICANCE OF THE EVENTS AND FATAL OUTCOME. THE CASE DID NOT QUALIFY AS AN MDR. HOWEVER, DUE TO SERIOUS UNEXPECTED EVENTS ENDOCARDITIS, CARDIOPULMONARY FAILURE AND MITRAL VALVE INCOMPETENCE, THE REPORT QUALIFIED AS A 15-DAY REPORT.
CASE REFERENCE NUMBER (B)(4) IS A SERIOUS *SOLICITED* REPORT INITIALLY RECEIVED FROM A NURSE ON 05-AUG-2021, WITH ADDITIONAL INFORMATION RECEIVED ON 06-AUG-2021, AND ON 10-AUG-2021 WHICH CONCERNS A 63 YEARS OLD MALE PATIENT WHO EXPERIENCED ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION- LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET, CARDIO-PULMONARY FAILURE AND SEPSIS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. *THE PATIENT DID NOT HAVE ALLERGIES TO VANCOMYCIN, AMIKACIN OR AMPHOTERICIN B. IT WAS REPORTED THAT THE PATIENT WAS SICK WITH MULTIPLE ISSUES. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THERMAL BURN (BURN MECHANISM WAS REPORTED AS FLAME). THE PATIENT REQUIRED VENTILATION FOR 156 DAYS. ON (B)(6) 2021, AT 08:40 AND AT 16:45 BIOPSY WAS PERFORMED TO THE LEFT GROIN AND LEFT AXILLA (EXPIRATION DATE ON TUBES 18-AUG-2021) AND SHOWED THAT TOTAL BODY SURFACE AREA (TBSA) AFFECTED WAS 80% (FULL THICKNESS 70% AND PARTIAL THICKNESS 10%). THERE WAS NO WOUND AND SYSTEMIC INFECTION. ON(B)(6) 2021, 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 (B)(6) 2019) 3T3 RESIDUAL ASSAY Q2C-136 WAS REPORTED AS LESS THAN 0.1 - PASS; 0.14 - PASS, 0.12 - PASS, LESS THAN 0.1 - PASS. ON (B)(6) 2021, 129 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO135844), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR 80% OF TBSA THERMAL BURNS. ON (B)(6) 2021, 84 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO136047), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR 80% OF TBSA THERMAL BURNS. ON (B)(6) 2021, 82 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO136484), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR 80% OF TBSA THERMAL BURNS. ON (B)(6) 2021, 72 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO136963), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR 80% OF TBSA THERMAL BURNS. ON (B)(6) 2021 LATE AFTERNOON, THE PATIENT WAS PLACED ON HOSPICE. ON (B)(6) 2021, AT 11:57, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CARDIO-PULMONARY FAILURE AND SEPSIS. IT WAS UNKNOWN IF THE 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 BLENDED INTO THE CASE NARRATIVE ABOVE, WITH THE LATEST INFORMATION PRESENTED BETWEEN ASTERISKS (*). FOLLOW-UP INFORMATION RECEIVED FROM SENIOR QUALITY CONTROL MANAGER ON 12-AUG-2021: NEW INFORMATION INCLUDED QC TESTS. FOLLOW-UP INFORMATION RECEIVED ON 17-SEP-2021: NEW INFORMATION INCLUDED INDICATION FOR EPICEL. DATE WHEN PATIENT WAS PLACED IN HOSPICE. CONFIRMATION THAT NO FURTHER INFORMATION WAS AVAILABLE FOLLOW-UP INFORMATION RECEIVED ON 29-APR-2022: THE PATIENT'S HEIGHT, WEIGHT, AND DATE OF THE BIOPSY WERE PROVIDED. THE CASE WAS REASSESSED FROM SPONTANEOUS TO SOLICITED. THE CASE IS CONSIDERED SOLICITED BECAUSE THE REPORT CAME FROM A PATIENT REGISTRY TITLED, EPICEL PATIENT REGISTRY. THE REPORTER'S CAUSALITY ASSESSMENT WAS PROVIDED AS NOT RELATED TO EPICEL. COMPANY COMMENT: SEPSIS IS EXPECTED, WHILE ENDOCARDITIS, CARDIOPULMONARY FAILURE, AND MITRAL VALVE INCOMPETENCE ARE UNEXPECTED ACCORDING TO THE EPICEL DIRECTIONS FOR USE (DFU). THE PATIENT DIED ALMOST FIVE MONTHS AFTER THE LAST EPICEL GRAFTING DUE TO CARDIO-PULMONARY FAILURE AND SEPSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF THE ANTERIOR MITRAL VALVE LEAFLET, BUT AN EXACT TIMELINE WAS NOT PROVIDED. THE PATIENT WAS SICK WITH MULTIPLE ISSUES AND HAD THERMAL BURNS. EXTENSIVE BURNS COULD HAVE PROVIDED AN ALTERNATIVE ETIOLOGY FOR ENDOCARDITIS AND SEPSIS WHICH CAUSED CARDIOPULMONARY FAILURE. NO INFORMATION REGARDING THE CLINICAL COURSE WAS PROVIDED. DESPITE THE TEMPORAL RELATIONSHIP AND NO EVIDENCE PROVIDED TO SUGGEST THAT EPICEL CAUSED THE EVENTS, THE REPORTER ASSESSED THE REPORT AS NOT RELATED TO EPICEL. THE CASE IS SERIOUS DUE TO THE MEDICAL SIGNIFICANCE OF THE EVENTS AND THE FATAL OUTCOME. THE CASE DID NOT QUALIFY AS AN MDR. THE EVENTS OF CARDIO-PULMONARY FAILURE AND ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET ARE SERIOUS AND UNEXPECTED. HOWEVER, THEY ARE UNRELATED TO THE PRODUCT. THUS, THIS 15-DAY REPORT IS BEING SUBMITTED DUE TO THE REASSESSMENT OF THE CASE FROM SPONTANEOUS TO SOLICITED.
CARDIO-PULMONARY FAILURE [CARDIOPULMONARY FAILURE]; ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET [MITRAL VALVE INCOMPETENCE]; ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET [ENDOCARDITIS]; SEPSIS [SEPSIS].
CARDIO-PULMONARY FAILURE [CARDIOPULMONARY FAILURE]; ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET [MITRAL VALVE INCOMPETENCE]; ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET [ENDOCARDITIS]; SEPSIS [SEPSIS].
CASE REFERENCE NUMBER (B)(4) IS A SERIOUS SPONTANEOUS REPORT INITIALLY RECEIVED FROM A NURSE ON (B)(6) 2021, WITH ADDITIONAL INFORMATION RECEIVED ON 06-AUG-2021, AND ON 10-AUG-2021 WHICH CONCERNS A(B)(6) YEARS OLD MALE PATIENT WHO EXPERIENCED ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION- LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET, CARDIO-PULMONARY FAILURE AND SEPSIS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS SICK WITH MULTIPLE ISSUES. ON (B)(6) 2021, 129 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO135844), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR THERMAL BURNS. ON (B)(6) 2021, 84 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO136047), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR THERMAL BURNS. ON (B)(6) 2021, 82 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO136484), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR THERMAL BURNS. ON (B)(6) 2021, 72 GRAFTS OF EPICEL (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE02739 (SO136963), EXPIRATION DATE: UNKNOWN) WERE USED ON THE PATIENT FOR THERMAL BURNS. IT WAS REPORTED THAT THE PATIENT WAS PLACED ON HOSPICE LATE THURSDAY AFTERNOON. ON (B)(6) 2021, AT 11:57, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CARDIO-PULMONARY FAILURE AND SEPSIS. IT WAS UNKNOWN IF THE AUTOPSY WAS PERFORMED. THE REPORTER'S CAUSALITY ASSESSMENT WAS PROVIDED AS NOT RELATED TO EPICEL. NO FURTHER INFORMATION WAS PROVIDED. CASE COMMENT: SEPSIS IS EXPECTED, WHILE ENDOCARDITIS, CARDIOPULMONARY FAILURE AND MITRAL VALVE INCOMPETENCE ARE UNEXPECTED ACCORDING TO THE EPICEL DFU. THE PATIENT DIED ALMOST FIVE MONTHS AFTER THE LAST EPICEL GRAFTING DUE TO CARDIO-PULMONARY FAILURE AND SEPSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MITRAL VALVE LEAFLET, BUT EXACT TIMELINE WAS NOT PROVIDED. THE PATIENT WAS SICK WITH MULTIPLE ISSUES AND HAD THERMAL BURNS. EXTENSIVE BURNS COULD HAVE PROVIDED AN ALTERNATIVE AETIOLOGY FOR ENDOCARDITIS AND SEPSIS WHICH CAUSED CARDIO-PULMONARY FAILURE. NO INFORMATION REGARDING CLINICAL COURSE WAS PROVIDED. HAVING IN MIND NOT SUGGESTIVE TEMPORAL RELATIONSHIP 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 MEDICAL SIGNIFICANCE OF THE EVENTS AND FATAL OUTCOME. THE CASE DID NOT QUALIFY AS AN MDR. HOWEVER, DUE TO SERIOUS UNEXPECTED EVENTS ENDOCARDITIS, CARDIOPULMONARY FAILURE AND MITRAL VALVE INCOMPETENCE, THE REPORT QUALIFIED AS A 15-DAY REPORT.
CARDIO-PULMONARY FAILURE; ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET [MITRAL VALVE INCOMPETENCE]; ENDOCARDITIS WITH ACUTE MITRAL VALVE REGURGITATION - LARGE MOBILE VEGETATION ON TIP OF ANTERIOR MV LEAFLET [MITRAL VALVE ENDOCARDITIS]; SEPSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238120 | EPICEL | CULTURED EPIDERMAL AUTOGRAFTS | OCE | VERICEL | EE02739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Other| D |