MAUDE Adverse Event Report: VERICEL EPICEL; CULTURED EPIDERMAL AUTOGRAFTS

Lot Number	EE03308
Medical Device Problem Codes	Leak/Splash (1354); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Loose pink liquid was noted on the outside of the cartridges in one sleeve of trays [product leakage] 8 grafts were scalloped form the edges [product quality issue].
Additional Manufacturer Narrative
Case reference number (b)(4) is a spontaneous report received from a company employee, on (b)(6) 2024, concerning a 12-year-old male patient who received epicel grafts.However, epicel grafts were received with some loose pink liquid noted on the outside of the cartridges in one sleeve of trays (pt: product leakage).On 14-jul-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 0.03 - pass.The patient's medical history and concomitant medication details were not reported.On (b)(6) 2024, a total of 64 (55 original and 9 extra) epicel grafts were received.On (b)(6) 2024, the patient received a total of 43 epicel grafts (cultured epidermal autografts, lot number: ee03308, expiration date: 15-jul-2024) for 70% total body surface area (tbsa) burn.On the same date, some loose pink liquid was noted on the outside of the cartridges in one sleeve of trays of epicel grafts (pt: product leakage).It was reported that no unsealed trays were found.Also, it was impossible to distinguish where the leak came from.On (b)(6) 2024, 8 grafts of the 96 grafts (86 ordered + 10 extra) were found scalloped from the edges (pt: product quality issue) and titanium clipes were not holding the graft to the edges of the backings.On the same date, the patient received epicel grafts (cultured epidermal autografts, lot number: ee03308, expiration date: unknown) for 70% total body surface area (tbsa) burn.At the time of the report, the outcome of the reported events was unknown.Additional information was received on 19-jul-2024, 31-jul-2024, 08-aug-2024 and 12-aug-2024 and processed together with the initial.No further information was provided.Company comment: vericel has assessed a product leakage as non-serious, possibly related and expected, and product quality issue as non-serious, possibly related and expected.The case qualifies as a mdr.
Event or Problem Description
Loose pink liquid was noted on the outside of the cartridges in one sleeve of trays [product leakage].
Additional Manufacturer Narrative
Case reference number: (b)(4) is a spontaneous report received from a company employee, on 15-jul-2024, concerning a 12-year-old male patient who received epicel grafts.However, epicel grafts were received with some loose pink liquid noted on the outside of the cartridges in one sleeve of trays (pt: product leakage).On 14-jul-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 0.03 - pass.The patient's medical history and concomitant medication details were not reported.On (b)(6) 2024, a total of 64 (55 original and 9 extra) epicel grafts were received.On (b)(6) 2024, the patient received a total of 43 epicel grafts (cultured epidermal autografts, lot number: ee03308, expiration date: 15-jul-2024) for full thickness burn.On the same date, some loose pink liquid was noted on the outside of the cartridges in one sleeve of trays of epicel grafts (pt: product leakage).It was reported that no unsealed trays were found.Also, it was impossible to distinguish where the leak came from.At the time of the report, the outcome of the reported events was unknown.Additional information was received on 19-jul-2024, 31-jul-2024, 08-aug-2024 and 12-aug-2024 and processed together with the initial.All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).Follow up information was received from the reporter on 13-aug-2024 and included lot number and expiration date of epicel grafts received on 05-aug-2024.Additional information was received on 25-aug-2024 and was processed together with the follow up 1.The need for significant correction was identified on 09-sep-2023 and included the removal of second grafting with epicel and the event of product quality issue, which will both be databased under the new case id.No further information was provided.This case is linked to case: (b)(4) (same patient).Company comment: vericel has assessed a product leakage as non-serious, possibly related and expected.The case qualifies as a mdr.

• Brand Name: EPICEL
• Common Device Name: CULTURED EPIDERMAL AUTOGRAFTS
• Manufacturer (Section D): VERICEL; 64 sydney st; cambridge MA 02139
• Manufacturer (Section G): VERICEL; 64 sydney st; cambridge MA 02139
• Manufacturer Contact: 64 sydney st; cambridge, MA 02139
• MDR Report Key: 19971238
• Report Number: 3002836339-2024-00083
• Device Sequence Number: 8941495
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2024
• Device Lot Number: EE03308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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
• Patient Age: 12 YR
• Patient Sex: Male