MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-06 for EPICEL manufactured by Vericel Corporation.
[84944957]
This initial spontaneous report was received from a physician on (b)(6) 2017, concerning a (b)(6) patient of an unknown age and race, who was grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with 48 units of epicel with lot number ee02216 on (b)(6) 2017. The relevant medical history and concomitant medications details were not provided. On (b)(6) 2017, the biopsy harvest was done. On an unspecified date in (b)(6) 2017, it was reported that after having an epicel graft, the patient passed away. It was also stated that the size of the burn was 93%. Therapeutic measures were not provided. Action taken with epicel was not applicable. The reporter did not provide a causality between the event and epicel. The company assessed the event of death as possibly related to epicel due to the limited information provided. The case will be re-assessed on receipt of follow up information. No additional information was provided at the time of reporting. Additional information was requested from the reporter and the case will be re-assessed upon receipt, if applicable.
Patient Sequence No: 1, Text Type: D, B5
[105926621]
Quality effected was reported as 48, sales order number was reported as so111851, no of grafts was reported as 48. Product part (b)(6). Device is not returned.
Patient Sequence No: 1, Text Type: N, H10
[105926622]
This initial spontaneous report was received from a physician via a sales representative on (b)(6) 2017, concerning a (b)(6) patient of an unknown race, who was grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with 48 units of epicel with lot number ee02216 on (b)(6) 2017. The relevant medical history and concomitant medications details were not provided. On (b)(6) 2017, the biopsy harvest was conducted. It was reported that the patient had endured 93% burns. On (b)(6) 2017, 22 days after receiving epicel implants, the patient had expired. Action taken with epicel was not applicable. The reporter did not provide a causality between the event and epicel. The company assessed the event of death as possibly related to epicel due to the limited information provided. The case will be re-assessed on receipt of follow up information. Additional information was received on (b)(6) 2017 from a physician via a sales representative. The patient was a (b)(6) male of an unspecified race. His height was 170. 1 cm and weight was (b)(6). The patient was prescribed with topical antimicrobial sulfamylon (mafenide acetate) and systemic antimicrobial cefepime cream. The qc sterility test was performed and results of pre-release sample type qc2-005 was passed and sterility test results of final product sample type qc2-012 were also reported as passed. Environmental results included personal monitoring of manufacturing which had passed with grade a and b parameters and personnel monitoring of qc sterility which had passed with grade a parameters. The quality control assay was reviewed which included qc2-027 graft inspection, qc2-094 dual stain assay, and qc2-010 endotoxin assay, all were reported as passed. The product part number was reported as au201 and sales order number was (b)(6). The quantity affected was reported as 48. The date of assembly was reported as (b)(6) 2017. On (b)(6) 2017, 22 days after receiving epicel graft the patient expired. The site of biopsy was right hip and the expiration date was (b)(6) 2017. The reporter causality was not provided. No other information was provided at the time of reporting. Additional information was requested from the reporter and the case will be re-assessed upon receipt, if applicable. The reporter causality was not provided. The company assessed the event of death as possibly related to epicel due to the limited information provided. The case will be re-assessed on receipt of follow up information.
Patient Sequence No: 1, Text Type: D, B5
[106170344]
Failed cea [graft failure]; case description: this initial spontaneous report was received from a physician via a sales representative on (b)(6) 2017, concerning a (b)(6) patient of an unknown race, who was grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with 48 units of epicel with lot number ee02216 on (b)(6) 2017. The relevant medical history and concomitant medications details were not provided. On (b)(6) 2017, the biopsy harvest was conducted. It was reported that the patient had endured 93% burns. On (b)(6) 2017, 22 days after receiving epicel implants, the patient had expired. Action taken with epicel was not applicable. The reporter did not provide a causality between the event and epicel. The company assessed the event of death as possibly related to epicel due to the limited information provided. The case will be re-assessed on receipt of follow up information. Additional information was received on (b)(6) 2017 from a physician via a sales representative. The patient was a (b)(6) male of an unspecified race. His height was 170. 1 cm and weight was (b)(6). The patient was prescribed with topical antimicrobial sulfamylon (mafenide acetate) and systemic antimicrobial cefepime cream. The qc sterility test was performed and results of pre-release sample type qc2-005 was passed and sterility test results of final product sample type qc2-012 were also reported as passed. Environmental results included personal monitoring of manufacturing which had passed with grade a and b parameters and personnel monitoring of qc sterility which had passed with grade a parameters. The quality control assay was reviewed which included qc2-027 graft inspection, qc2-094 dual stain assay, and qc2-010 endotoxin assay, all were reported as passed. The product part number was reported as au201 and sales order number was (b)(4). The quantity affected was reported as 48. The date of assembly was reported as (b)(6) 2017. On (b)(6) 2017, 22 days after receiving epicel graft the patient expired. The site of biopsy was right hip and the expiration date was (b)(6) 2017 the reporter causality was not provided. No other information was provided at the time of reporting. Additional information was requested from the reporter and the case will be re-assessed upon receipt, if applicable. The reporter causality was not provided. The company assessed the event of death as possibly related to epicel due to the limited information provided. The case will be re-assessed on receipt of follow up information. Additional information was received on (b)(6) 2017 from a nurse practitioner. The patient was hospitalized on (b)(6) 2017 following self-extrication from a recreational vehicle (rv) fire in which he sustained 92. 5% total body surface area burns (including second and third-degree burns) along with acute respiratory failure, acute pain due to injury, burn shock, nutritional deficiency, reduced mobility, hypocalcemia, hypokalemia, laceration of the arm. Upon admission, burns were cleaned with soap and water and devitalized tissue was removed. The pain was controlled with intravenous narcotics. Since that time, he had undergone repeat tangential excisions of his burns with a combination of allograft, xenograft, and cultured epithelial autograft with poor graft uptake. The patient also had a failed cultured epidermal autograft (cea). His care was complicated due to multiple blood, lung, and skin infections with a combination of (b)(6), acinetobacter, stenotrophomonas and aspergillus, for which he was on and off of antibiotics. The patient also developed acute renal failure for which hemodialysis (hd) and later continuous renal replacement therapy (crrt) was utilized. The patient also experienced sepsis and fungal infection of the skin. The patient was an alcohol user and had no known allergies. Concomitant medications included sublimaze (fentanyl), dolophine (methadone hydrochloride), versed (midazolam hydrochloride), acetaminophen (paracetamol), dilaudid (hydromorphone hydrochloride), avitene (collagen), and roxicodone (oxycodone hydrochloride). It was reported that in general, the patient was resting in bed comfortably with no acute distress, had regular heart rate and was breathing comfortably on room air. The patient had an open abdomen and intestines in silastic mesh, and his extremities were reacting to pain. On (b)(6) 2017, the patient's blood pressure was measured as 91/31 at 19:00 pm. On (b)(6) 2017, it was noted that the patient was becoming more acidotic due to which his ventilator settings were increased. On (b)(6) 2017, after discussing with his family the patient was made comfort care, and hence his vent settings were turned down to minimal, his drips and fluids were stopped, wound care was discontinued and narcotics were increased for increased work of breathing. On (b)(6) 2017, at approximately 19:44 pm, it was noted that the patient stopped breathing, his pulse rate was noted as 20 at 19:50 pm. On the same day, at 20:01, the patient was in asystole due to cardiovascular collapse, hypoxemic respiratory failure, severe 92. 5% tbsa burns with multiple infections and organ failure. Upon physical examination it was revealed that there was lack of pulse breathing, and no pupillary reaction. On (b)(6) 2017, the patient was examined and in agreement with the family, the support was withdrawn. The outcome was fatal. Action taken with epicel was not applicable. The reporter stated that the death was not related to epicel. The company assessed the events of infection, organ failure, cardiovascular collapse and respiratory failure as not related to epicel. The patient death was assessed by the company as not related to epicel but related to complications of burns. The company assessed the event of graft failure as possibly related to epicel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2017-00008 |
| MDR Report Key | 6844333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-06 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-06 |
| 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 | MS. LIZ GREKAS |
| Manufacturer Street | 64 SIDNEY STREET CAMBRIDGE |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer G1 | VERICEL CORPORATION |
| Manufacturer Street | 64 SIDNEY STREET CAMBRIDGE |
| 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 |
| Brand Name | EPICEL |
| Generic Name | EPICEL |
| Product Code | OCE |
| Date Received | 2017-09-06 |
| Lot Number | EE02216 |
| Device Expiration Date | 2017-12-07 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | 64 SIDNEY STREET CAMBRIDGE CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2017-09-06 |