MAUDE Adverse Event Report: VERICEL EPICEL; CULTURED EPIDERMAL AUTOGRAFTS

Lot Number	EE03344
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Coagulation Disorder (1779); Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	12/06/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Case reference number (b)(4) is a spontaneous report *initially* received from a non-healthcare professional on (b)(6) 2024, concerning a 32-year-old male patient who expired after grafting with epicel.*on (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.* the patient's medical history included von willebrand's disease.The patient's concomitant medication details were not reported.On (b)(6) 2024, the patient received epicel grafts (cultured epidermal autografts) (lot number: ee03344, expiration date: 14-nov-2024) for burn over 30% total body surface area (tbsa).On (b)(6) 2024, graft takedown was performed and 98 percent (%) of graft take was achieved on back and right lower anterior thigh.Surgical procedure was tolerated well by patient with vital signs within normal limits.On (b)(6) 2024, patient was taken to operating room (or) for chest debridement.On (b)(6) 2024, the patient developed *transfusion-associated related* thrombocytopenia (pt: thrombocytopenia) and sepsis (pt: sepsis), per burn team.The plan was to get platelet count up before the next graft date.However, the patient's platelet count continued to stay low, even with multi blood products administered.On (b)(6) 2024, the patient was placed on comfort care.*on an unknown date, the patient experienced pulmonary hemorrhage (pt: pulmonary hemorrhage) secondary to multiple synchronized cardioversions for medication refractory atrial fibrillation (pt: atrial fibrillation) in the setting of transfusion-associated related thrombocytopenia.* on (b)(6) 2024, patient passed away *due to pulmonary hemorrhage*.On (b)(6) 2024, hospital team was notified.The events of *transfusion-associated related* thrombocytopenia and sepsis were assessed as serious due to hospitalization and medical significance.*the events of pulmonary hemorrhage and medication refractory atrial fibrillation were assessed as serious due to medical significance and fatal outcome.* the reporter did not provide a causality assessment for the events.No further information was provided.All follow-up information is included in the case narrative above, with the latest information presented between asterisks (*).Follow-up information was received from the reporter on (b)(6) 2024 and included qc results.Additional information was received on 07-jan-2025 and processed together with the follow-up.Company comment: vericel has assessed the event of pulmonary hemorrhage as serious, not related and unexpected, the event of atrial fibrillation as serious, not related and unexpected, the event of thrombocytopenia as serious, not related and expected, and the event of sepsis as serious, possibly related and expected per epicel ifu.The case does not qualify as an mdr and qualifies as a 15-day-report.
Event or Problem Description
Pulmonary hemorrhage [pulmonary haemorrhage] medication refractory atrial fibrillation [atrial fibrillation] transfusion-associated related thrombocytopenia [thrombocytopenia] sepsis [sepsis].

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

64 sydney st

cambridge, MA 02139

• MDR Report Key: 21147255
• Report Number: 3002836339-2024-00138
• Device Sequence Number: 21141408
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 11/14/2024
• Device Lot Number: EE03344
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/14/2025
• 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: Other; Death; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male