EPICEL AU201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-14 for EPICEL AU201 manufactured by Vericel Corporation.

Event Text Entries

[72806276] Case description: this spontaneous report was received from a nurse via a sales representative on (b)(4) 2017, concerning a (b)(6) year-old female child patient weighing (b)(6) who expired after being grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with one unit of epicel with lot number ee02158 for 85% total body surface area (tbsa) full thickness burns. Medical history was not reported and concomitant medication included topical antimicrobial or antifungal medications such as silvadine (silver sulfadiazine), bacitracin and nystatin. Allergies were ruled out to vancomycin, amikacin and amphotericin b. No other significant dermatological history reported. On (b)(6) 2017, the patient was injured and on the same day patient was hospitalized with 85% tbsa burn. On (b)(6) 2017, a biopsy was performed on right axilla and left groin. No wound or systemic infection of microbial and fungal origin were reported. Qc sterility test results of pre-release sample type from (b)(6) 2017 and of final product sample type from (b)(6) 2017 were negative. On (b)(4) 2017, the quality control assay was reviewed which included (b)(4) graft inspection, (b)(4) dual stain and (b)(4) endotoxin interpreted as passed. Environmental results: personnel monitoring of manufacturing passed in grade a and b parameters. The personnel monitoring of qc sterility passed with grade a parameters. On (b)(6) 2017, the patient underwent surgery and was grafted with one unit of cultured epidermal autografts lot number ee02158, product part number au201 and sales order number (b)(4) for 85% tbsa full thickness burns. The patient was implanted with 16 grafts of epicel. On (b)(6) 2017, the patient expired from on unknown cause. Details regarding treatment was not provided. Further details including description of clinical presentations, signs, symptoms, diagnostic tests, baseline data, and diagnosis, cause of death and autopsy results were not reported. Outcome: fatal. Seriousness criterion: death. The reporter's causality between the event patient expired and epicel grafts was not provided. The company causality is considered possibly related, with the available information. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1226230-2017-00002
• MDR Report Key: 6493140
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2017-04-14
• Date of Report: 2017-03-23
• Date of Event: 2017-03-22
• Report Date: 2017-03-23
• Date Reported to Mfgr: 2017-03-23
• Date Mfgr Received: 2017-03-23
• Date Added to Maude: 2017-04-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: LIZ GREKAS
• Manufacturer Street: 64 SIDNEY STREET
• Manufacturer City: CAMBRIDGE MA 02139
• Manufacturer Country: US
• Manufacturer Postal: 02139
• Manufacturer G1: VERICEL CORPORATION
• Manufacturer Street: 64 SIDNEY STREET
• Manufacturer City: CAMBRIDGE MA 02139
• Manufacturer Country: US
• Manufacturer Postal Code: 02139
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPICEL
• Generic Name: CULTURED EPIDERMAL AUTOGRAFTS
• Product Code: OCE
• Date Received: 2017-04-14
• Model Number: AU201
• Lot Number: EE02158
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VERICEL CORPORATION
• Manufacturer Address: 64 SIDNEY STREET CAMBRIDGE, MA 02139 US 02139

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2017-04-14