EPICEL
Report
- Report Number
- 1226230-2017-00001
- Event Type
- Death
- Date Received
- February 3, 2017
- Date of Event
- November 14, 2016
- Report Date
- April 1, 2017
- Manufacturer
- VERICEL CORPORATION
- Product Code
- MGQ
- PMA / PMN Number
- HDE 99002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
40 GRAFTS; SALES ORDER NUMBER (B)(4).
FORTY GRAFTS; SALES ORDER NUMBER (B)(4).
CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL VIA A SALES REPRESENTATIVE ON 04-JAN-2017, CONCERNING AN (B)(6) MALE PATIENT (B)(6) WHO EXPIRED AFTER BEING GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). THE PATIENT WAS GRAFTED WITH 40 UNITS OF EPICEL WITH LOT NUMBER EE02114 FOR FULL THICKNESS BURNS. DETAILS REGARDING MEDICAL HISTORY WAS NOT PROVIDED AND CONCOMITANT MEDICATION REPORTED INCLUDED VASHE (TOPICAL ANTIFUNGAL), ANCEF (CEFAZOLIN SODIUM) AND ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM) AS SYSTEMIC ANTIFUNGAL. ALLERGIES WERE RULED OUT TO VANCOMYCIN, AMIKACIN AND AMPHOTERICIN B. NO OTHER SIGNIFICANT DERMATOLOGICAL HISTORY REPORTED. ON (B)(6) 2016, THE PATIENT WAS INJURED AND HOSPITALIZED. ON (B)(6) 2016, A BIOPSY WAS PERFORMED ON RIGHT GROIN AND RIGHT AXILLA. NO WOUND OR SYSTEMIC INFECTION OF MICROBIAL AND FUNGAL ORIGIN WERE REPORTED. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY AND WAS GRAFTED WITH 40 UNITS OF CULTURED EPIDERMAL AUTOGRAFTS WITH LOT NUMBER EE02114, PRODUCT PART NUMBER AU201 AND SALES ORDER (B)(4). ON AN UNSPECIFIED DATE AFTER THE GRAFT, THE PATIENT EXPIRED FROM AN UNKNOWN CAUSE. DETAILS REGARDING TREATMENT WAS NOT PROVIDED. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATION, SIGNS, SYMPTOMS, DIAGNOSTIC TESTS, BASELINE DATA, DIAGNOSIS, CAUSE OF DEATH AND AUTOPSY RESULTS WERE NOT REPORTED. OUTCOME: FATAL. SERIOUSNESS CRITERION: DEATH. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. THE COMPANY CONSIDERS THE DEATH AS POSSIBLY RELATED TO EPICEL IN THE ABSENCE OF ANY OTHER INFORMATION REGARDING THE CAUSE OF DEATH AND BASED ON THE CONDITIONS OF THE HUMANITARIAN DEVICE EXEMPTION. ADDITIONAL INFORMATION WAS RECEIVED ON 31-JAN-2017 FROM A STAFF NURSE. THE NURSE REPORTED THAT THE PATIENT WAS ON COMFORT CARE MEASURES PRIOR TO DEATH AND EXPIRED ON (B)(6) 2016. THE CAUSE OF DEATH WAS REPORTED AS MULTI SYSTEM ORGAN FAILURE. QC STERILITY TEST RESULTS OF PRE-RELEASE SAMPLE TYPE FROM (B)(6) 2016 AND OF FINAL PRODUCT SAMPLE TYPE FROM (B)(6) 2016 WERE BOTH NEGATIVE. ENVIRONMENTAL RESULTS: PERSONNEL MONITORING OF MANUFACTURING PASSED IN GRADE A AND B PARAMETERS AND PERSONNEL MONITORING OF QC STERILITY PASSED WITH GRADE A PARAMETERS. ON (B)(6) 2016, THE QUALITY CONTROL ASSAY WERE REVIEWED WHICH INCLUDED QC2-027 GRAFT INSPECTION (40 GRAFTS AVAILABLE FOR SHIPMENT), QC2-094 DUAL STAIN (50-75%) AND QC2-010 ENDOTOXIN (<1%) AS PASSED. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. THE COMPANY CONSIDERS THE DEATH AS NOT RELATED TO EPICEL AS THE MULTI SYSTEM ORGAN FAILURE COULD BE THE CLINICAL COURSE FOLLOWING EXTENSIVE INJURY AND SURGERY WITH MULTIPLE GRAFTS. FURTHER DETAILS ABOUT THE COURSE OF THE PATIENT'S HOSPITALIZATION LEADING TO MULTIORGAN FAILURE IS AWAITED. NO NEW ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 03-MAR-2017: THE ADDITIONAL ENVIRONMENTAL TESTS PERFORMED ON (B)(6) 2017 FOR THE PERSONNEL MONITORING OF MANUFACTURING INCLUDED VIABLE AIR PARTICULATES AND SLEEVE PLATE TEST WHICH SHOWED PASSED RESULTS IN GRADE A EXCEPT FOR SCP ( DISPASER ) THE ORGANISM WAS A GRAM - ROD; ID - CHRYSEOBACTERIUM TAKLIMAKANESE. ADDITIONAL TESTS FOR THE PERSONNEL MONITORING OF QC STERILITY INCLUDED SLEEVE PLATE TEST WHICH ALSO SHOWED PASSED RESULTS WITH GRADE A PARAMETERS. NO NEW ADDITIONAL INFORMATION WAS PROVIDED.
THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL VIA A SALES REPRESENTATIVE ON (B)(6) 2017, CONCERNING AN (B)(6) MALE PATIENT WEIGHING (B)(6) WITH HEIGHT (B)(6) WHO EXPIRED AFTER BEING GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). THE PATIENT WAS GRAFTED WITH 40 UNITS OF EPICEL WITH LOT NUMBER EE02114 FOR FULL THICKNESS BURNS. DETAILS REGARDING MEDICAL HISTORY WAS NOT PROVIDED AND CONCOMITANT MEDICATION REPORTED INCLUDED VASHE (TOPICAL ANTIFUNGAL), ANCEF (CEFAZOLIN SODIUM) AND ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM) AS SYSTEMIC ANTIFUNGAL. ALLERGIES WERE RULED OUT TO VANCOMYCIN, AMIKACIN AND AMPHOTERICIN B. NO OTHER SIGNIFICANT DERMATOLOGICAL HISTORY REPORTED. ON (B)(6) 2016, THE PATIENT WAS INJURED AND HOSPITALIZED. ON (B)(6) 2016, A BIOPSY WAS PERFORMED ON RIGHT GROIN AND RIGHT AXILLA. NO WOUND OR SYSTEMIC INFECTION OF MICROBIAL AND FUNGAL ORIGIN WERE REPORTED. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY AND WAS GRAFTED WITH 40 UNITS OF CULTURED EPIDERMAL AUTOGRAFTS WITH LOT NUMBER EE02114, PRODUCT PART NUMBER AU201 AND SALES ORDER NUMBER (B)(4). ON AN UNSPECIFIED DATE AFTER THE GRAFT, THE PATIENT EXPIRED FROM AN UNKNOWN CAUSE. DETAILS REGARDING TREATMENT WAS NOT PROVIDED. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATION, SIGNS, SYMPTOMS, DIAGNOSTIC TESTS, BASELINE DATA, DIAGNOSIS, CAUSE OF DEATH AND AUTOPSY RESULTS WERE NOT REPORTED. OUTCOME: FATAL SERIOUSNESS CRITERION: DEATH THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. THE COMPANY CONSIDERS THE DEATH AS POSSIBLY RELATED TO EPICEL IN THE ABSENCE OF ANY OTHER INFORMATION REGARDING THE CAUSE OF DEATH AND BASED ON THE CONDITIONS OF THE HUMANITARIAN DEVICE EXEMPTION.
THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL VIA A SALES REPRESENTATIVE ON 04-JAN-2017, CONCERNING AN (B)(6) MALE PATIENT WEIGHING (B)(6) WITH HEIGHT (B)(6) WHO EXPIRED AFTER BEING GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). THE PATIENT WAS GRAFTED WITH 40 UNITS OF EPICEL WITH LOT NUMBER EE02114 FOR FULL THICKNESS BURNS. DETAILS REGARDING MEDICAL HISTORY WAS NOT PROVIDED AND CONCOMITANT MEDICATION REPORTED INCLUDED VASHE (TOPICAL ANTIFUNGAL), ANCEF (CEFAZOLIN SODIUM) AND ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM) AS SYSTEMIC ANTIFUNGAL. ALLERGIES WERE RULED OUT TO VANCOMYCIN, AMIKACIN AND AMPHOTERICIN B. NO OTHER SIGNIFICANT DERMATOLOGICAL HISTORY REPORTED. ON (B)(6) 2016, THE PATIENT WAS INJURED AND HOSPITALIZED. ON (B)(6) 2016, A BIOPSY WAS PERFORMED ON RIGHT GROIN AND RIGHT AXILLA. NO WOUND OR SYSTEMIC INFECTION OF MICROBIAL AND FUNGAL ORIGIN WERE REPORTED. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY AND WAS GRAFTED WITH 40 UNITS OF CULTURED EPIDERMAL AUTOGRAFTS WITH LOT NUMBER EE02114, PRODUCT PART NUMBER AU201 AND SALES ORDER NUMBER (B)(4). ON AN UNSPECIFIED DATE AFTER THE GRAFT, THE PATIENT EXPIRED FROM AN UNKNOWN CAUSE. DETAILS REGARDING TREATMENT WAS NOT PROVIDED. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATION, SIGNS, SYMPTOMS, DIAGNOSTIC TESTS, BASELINE DATA, DIAGNOSIS, CAUSE OF DEATH AND AUTOPSY RESULTS WERE NOT REPORTED. OUTCOME: FATAL SERIOUSNESS CRITERION: DEATH. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. THE COMPANY CONSIDERS THE DEATH AS POSSIBLY RELATED TO EPICEL IN THE ABSENCE OF ANY OTHER INFORMATION REGARDING THE CAUSE OF DEATH AND BASED ON THE CONDITIONS OF THE HUMANITARIAN DEVICE EXEMPTION. ADDITIONAL INFORMATION WAS RECEIVED ON 31-JAN-2017 FROM A STAFF NURSE. THE NURSE REPORTED THAT THE PATIENT WAS ON COMFORT CARE MEASURES PRIOR TO DEATH AND EXPIRED ON (B)(6) 2016. THE CAUSE OF DEATH WAS REPORTED AS MULTI SYSTEM ORGAN FAILURE. QC STERILITY TEST RESULTS OF PRE-RELEASE SAMPLE TYPE FROM 10-DEC-2016 TO 24-DEC-2016 AND OF FINAL PRODUCT SAMPLE TYPE FROM 14-DEC-2016 TO 28-DEC-2016 WERE BOTH NEGATIVE. ENVIRONMENTAL RESULTS: PERSONNEL MONITORING OF MANUFACTURING PASSED IN GRADE A AND B PARAMETERS AND PERSONNEL MONITORING OF QC STERILITY PASSED WITH GRADE A PARAMETERS. ON 14-DEC-2016, THE QUALITY CONTROL ASSAY WERE REVIEWED WHICH INCLUDED QC2-027 GRAFT INSPECTION (40 GRAFTS AVAILABLE FOR SHIPMENT), QC2-094 DUAL STAIN (50-75%) AND QC2-010 ENDOTOXIN (<1%) AS PASSED. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. THE COMPANY CONSIDERS THE DEATH AS NOT RELATED TO EPICEL AS THE MULTI SYSTEM ORGAN FAILURE COULD BE THE CLINICAL COURSE FOLLOWING EXTENSIVE INJURY AND SURGERY WITH MULTIPLE GRAFTS. FURTHER DETAILS ABOUT THE COURSE OF THE PATIENT'S HOSPITALIZATION LEADING TO MULTIORGAN FAILURE IS AWAITED. NO NEW ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84778 | EPICEL | EPICEL | MGQ | VERICEL CORPORATION | AU201 | EE02114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death| H | ANCEF /(B)(4)/ (CEFAZOLIN SODIUM)| ANTIFUNGALS FOR DERMATOLOGICAL USE| ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM) |