MAUDE Adverse Event Report: VERICEL EPICEL; CULTURED EPIDERMAL AUTOGRAFTS

Lot Number	EE03325
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Disseminated Intravascular Coagulation (DIC) (1813)
Date of Event	09/11/2024
Type of Reportable Event	Death
Event or Problem Description
Disseminated intravascular coagulation (dic) [disseminated intravascular coagulation].
Additional Manufacturer Narrative
Case reference number (b)(4) is a spontaneous report received from a healthcare professional on 12-nov-2024, concerning a 23-year-old male patient who experienced disseminated intravascular coagulation (dic) (pt: disseminated intravascular coagulation) and expired after grafting with epicel.On (b)(6) 2024 and (b)(6) 2024, 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 less than 0.1 - pass; 0.13 - pass.The patient's medical history was not reported.The patient's concomitant medication details were not reported.On 03-sep-2024, the patient received 144 grafts of epicel (cultured epidermal autografts) (lot number: ee03325, expiration date: 03-sep-2024) for 90% total body surface area (tbsa).On (b)(6) 2024, the patient had secondary grafting with epicel.The patient received 144 grafts of epicel (cultured epidermal autografts) (lot number: ee03325, expiration date: 24-sep-2024) for 90% total body surface area (tbsa).On (b)(6) 2024, the patient experienced disseminated intravascular coagulation (dic) (pt: disseminated intravascular coagulation) and passed away.The event of disseminated intravascular coagulation was assessed as serious due to medical significance and fatal outcome.The reporter did not provide a causality assessment for the reported event.No further information was provided.Additional information was received on 15-nov-2024 and 21-nov-2024 and processed with the initial.Company comment: the patient experienced disseminated intravascular coagulation and eventually died approximately 7 weeks after receiving cultured epithelial autografts (cea).Disseminated intravascular coagulation is considered unexpected.The patient had extensive burns of 90% of total body surface area.No information regarding relevant medical history, concomitant medications, clinical course or autopsy report (if performed) was provided.The patient had an overall predicted mortality rate based on their initial injuries of 70-86% (modified baux score).Burn patients with large burns are known to suffer from hypercoagulable disorders, such as dic due to the high incidence of blood transfusions and sepsis.The overall severity and predicted mortality of the injury offer a more plausible explanation for the for the events of dic and death.There is no evidence to suggest that cea caused the events, causality is therefore assessed as not related.The case is serious due to medical significance of the event and fatal outcome.There is no temporal relationship between the grafts and the dic, therefore dic is considered unrelated to the grafting procedure.The report did not qualify as a medical device report, but qualifies as a 15-day-report since the events are unexpected and serious.

• Brand Name: EPICEL
• Common Device Name: CULTURED EPIDERMAL AUTOGRAFTS
• Manufacturer (Section D): VERICEL; 64 sydney st; cambridge MA 02139
• Manufacturer (Section G): VERICEL; 63 sydeny st; cambridge MA 02139

64 sydney st

cambridge, MA 02139

• MDR Report Key: 20794715
• Report Number: 3002836339-2024-00101
• Device Sequence Number: 20514895
• Product Code: OCE
• UDI-Device Identifier: W41020AU201S1969
• UDI-Public: W41020AU201S1969
• Combination Product (Y/N): Y
• PMA/510(K) Number: 990200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2024
• Device Lot Number: EE03325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 22 YR
• Patient Sex: Male