FDA.reportPublic FDA data

MAUDE MDR 6996783

MDR report key
6996783
Report number
1226230-2017-00009
Event key
0
Event type
3
Date of event
2015-06-14
Date received
2017-11-02
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LIZ GREKAS
Address
64 SIDNEY STREET CAMBRIDGE MA 02139 US
Phone
617-617-6175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EPICELCULTURED EPIDERMAL AUTOGRAFTS (EPICEL)VERICEL CORPORATIONOCEAU201EE01842* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-0201. D

Event Narratives#

N

Patient 1

TOTAL NUMBER OF GRAFTS: 144.

D

Patient 1

THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA A CUSTOMER CARE REPRESENTATIVE ON 06-OCT-2017, CONCERNING A (B)(6) MALE PATIENT- (B)(6) WHO EXPIRED AFTER BEING GRAFTED WITH CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). THE PATIENT WAS GRAFTED WITH 144 UNITS OF EPICEL WITH LOT NUMBER EE01842 FOR 90% TOTAL BODY SURFACE AREA (TBSA) FULL THICKNESS BURNS. THE RELEVANT MEDICAL HISTORY INCLUDED 90% TOTAL BODY SURFACE THERMAL BURNS. CONCOMITANT MEDICATION DETAILS WERE NOT REPORTED. ALLERGIES WERE RULED OUT TO VANCOMYCIN, AMIKACIN AND AMPHOTERICIN B. NO OTHER SIGNIFICANT DERMATOLOGY HISTORY REPORTED. ON (B)(6) 2014, THE PATIENT WAS INJURED AND WAS HOSPITALIZED WITH 90% TBSA BURN. ON (B)(6) 2014 AT 12:00 AM, THE BIOPSY WAS HARVESTED FROM LEFT GROIN AND LEFT LOWER ABDOMEN. THE PATIENT HAD MICROBIAL WOUND INFECTION (STENOTROPHOMONAS MALTOPHILIA, ENTEROBACTER CLOACAE, AND KLEBSIELLA PNEUMONIAE). IT WAS REPORTED THAT THE PATIENT UNDERWENT THREE GRAFTING SURGERIES, I.E. ON (B)(6) 2014 AND IN EACH TIME HE WAS GRAFTED WITH 48 UNITS (A TOTAL OF 144 GRAFTS) OF CULTURED EPIDERMAL AUTOGRAFTS WITH LOT NUMBERS EE01842, EE01842A AND EE01842B, RESPECTIVELY, FOR 90% TBSA FULL THICKNESS BURNS. THE PRODUCT PART NUMBER WAS AU201 AND THE SALE ORDER NUMBER WAS NOT REPORTED. QC STERILITY TEST RESULTS OF THE PRE-RELEASE SAMPLE AND OF FINAL PRODUCT SAMPLE TYPE PASSED THE QUALITY CONTROL LOT RELEASE ASSAYS. ON 12-OCT-2017, THE QUALITY CONTROL ASSAY WAS REVIEWED WHICH INCLUDED QC2-027 GRAFT INSPECTION, QC2-094 DUAL STAIN, AND QC2-010 ENDOTOXIN AND THESE WERE INTERPRETED AS PASSED. THE PERSONNEL MONITORING OF MANUFACTURING PASSED IN GRADE A AND B PARAMETERS. THE PERSONNEL MONITORING OF QC STERILITY PASSED IN GRADE A PARAMETERS. ON (B)(6) 2015, THE PATIENT EXPIRED DUE TO AN UNSPECIFIED REASON. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATIONS, SIGNS, SYMPTOMS, DIAGNOSTIC TESTS, AND BASELINE DATA, DIAGNOSIS, AND AUTOPSY RESULTS WERE NOT PROVIDED. THE OUTCOME WAS FATAL. ACTION TAKEN WITH EPICEL WAS NOT APPLICABLE. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN DEATH AND EPICEL. BASED ON THE LIMITED INFORMATION AVAILABLE ON THE POSSIBLE CAUSE OF DEATH, THE COMPANY ASSESSED THE EVENT OF DEATH AS POSSIBLY RELATED TO EPICEL. EVENT WILL BE REASSESSED ON RECEIPT OF FOLLOW UP INFORMATION.