EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-10-14 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).

Event Text Entries

[1736060] Pseudomonas wound infection [wound infection pseudomonas], candida wound infection, fusarium species wound infection [wound infection fungal], (b)(6), acinetobacter wound infection, escherichia coli, (b)(6), klebsiella, enterobacter wound inf [wound infection bacterial], blistering and shearing [blister], pruritus and itching [pruritus], contractures [muscle contracture], delayed loss of cultured epithelial autografts [graft loss], sepsis [sepsis], multiorgan failure [multi-organ failure], death [death]. Case description: a published article in (b)(6) titled "cultured epithelial autografts for coverage of large burn wounds in eighty-eight pts: the indiana university experience. " journal of burn care & research 2010; 31:559-568 (sood, r. , roggy, d. Zieger, m. , balledeux, j. , chaudhari, s. , koumanis, d. , mir, h. , cohen, a. , knipe, c. , gabehart, k. , coleman, j. ) was rec'd on (b)(6) 2010. A new technique for coverage of large burns, which begins with early tangential excision and coverage with cadaver allograft (a), followed by placement of cultured epithelial autograft (cea) onto an allodermis base (cea/a) has been used since 1990. A review of prospectively collected data was conducted on adult and pediatric pts grafted with cultured epithelial autograft (cea) for definitive wound coverage (total body surface area (tbsa) 28-98%). This series documented the outcomes of 88 pts (20 children and 68 adults) with large burns that were treated with the cea/a technique over an 18-year period, from 1990-2008. The age range of this pt population was from (b)(6), with a mean of (b)(6). The tbsa burned in this study group ranged from 28 to 98%, with a mean of 58. 5%. The tbsa of full-thickness burns ranged from 0 to 94%, with a mean of 51. 2%. The mechanism of burn injuries were flame (n=78), scald (n=9), and chemical (n=1). The mean abbreviated burn severity index was 9. 69. The overall survival rate in this study group was 91% (80 of 88% pts). The majority of adult pts (defined as older than 18 yrs) had pre hospital comorbidities including: tobacco use, ethanol abuse, drug abuse, hypertension, asthma, arrhythmia, (b)(6), neurologic, factor vii deficiency, non-insulin-dependent diabetes mellitus and renal failure. Pts went to the operating room an average of 9 times. The average number of operations for allograft maintenance was 4. 9, with a mean of 20. 1 square feet of allograft used (allografts usage data was unavailable for six pts). The mean time to cea placement was 30. 6 days. The mean tbsa covered with autografts was 25. 6%, whereas the mean tbsa covered with cea/a technique was 31. 2%. The take of cea was defined as the percent body surface area (bsa) with permanent coverage by the cea/a technique not requiring regrafting or any other forms of coverage. The average take of cea sheets to the underlying allodermis was 72. 1% after 1 week and 67. 4% at 21 days postoperative. At the time of discharge, the average final take rate for 88 pts was 72. 7%. In stratifying pts to "large" (>50% tbsa; n=64) or "small" (<50% tbsa; n=2), the health care providers found take rates to be comparable being 72. 1 and 74. 3%, respectively. Intraoperative wound cultures grew pseudomonas, candida, (b)(6), acinetobacter, and (b)(6). These infections were treated with both topical antimicrobial agents and systemic antibiotics with consideration to overall medical condition of the pt. In the 88 pt series, 8 pts died from sepsis, multi organ system failure, or a combination of the two. Their deaths were not attributed to the use of cea. Excluding the eight mortalities, the average length of stay was 99 days for the 20 children and 79. 9 days for the 68 adults (40 of the 68 with inhalation injuries). Early complications of cea use included blistering and shearing in (31%), pruritis and itching (4. 7%). Long-term complications included delayed loss of cea (n=2), requiring repeat coverage, and contractures, defined by a decrease in active range of motion or a limitation in activities of daily living as measured by therapists (57 pts [64%]). Contractures were found to be more common in children (18-20 pediatric pts [57%]). Burn scar contractures releases with integra were required as a result of functional limitations in activities of daily living after progress plateaued with physical and/or occupation therapy in 32 pts (36%), 56% (n=18) of which were children. At discharge, 30% of pts were sent home, whereas the remaining 70% were admitted to rehabilitation institutions. F/u ranged from 3 to 90 months during the last 18 yrs, with an average f/u length of 19. 1 months. At the time of this report, the outcome of the pt adverse events was unk. The author did not provide causality assessment. Mfr's comment: the benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226230-2010-00004
MDR Report Key1899005
Report Source03,05
Date Received2010-10-14
Date of Report2010-10-04
Date Mfgr Received2010-10-04
Date Added to Maude2011-12-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactEDWARD GILL, MD
Manufacturer Street675 WEST KENDALL STREET
Manufacturer CityCAMBRIDGE MA 02142
Manufacturer CountryUS
Manufacturer Postal02142
Manufacturer Phone8007454447
Manufacturer G1GENZYME BIOSURGERY (CAMBRIDGE)
Manufacturer Street64 SIDNEY STREET
Manufacturer CityCAMBRIDGE MA 02139
Manufacturer CountryUS
Manufacturer Postal Code02139
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT
Generic NameCULTURED EPIDERMAL AUTOGRAFTS
Product CodeOCE
Date Received2010-10-14
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGENZYME BIOSURGERY (CAMBRIDGE)
Manufacturer AddressCAMBRIDGE MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other 2010-10-14

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